Medical Device
Manufacturing
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Medtronic, Inc.

Deland, FL, US

Medtronic, Inc. appears in FDA device records in Deland, FL. FDA records list 1,525 510(k) clearances between and , 7,911 PMA records and 40 registered establishments. As of , FDA records show 2,578 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1,525
PMA records
7,911
Recall records
2,578
Registered establishments
40

FDA records under these names

44 names

FDA records resolved to Medtronic, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Allegiance Healthcare Corporation510(k), recall
  • Barrx Medical, Inc.510(k), recall
  • Cardinal Health 200, LLCregistration, 510(k), enforcement report, recall
  • Cardinal Health K.K.registration, 510(k), enforcement report, recall
  • Cardinal Health NeuroCare Divisionrecall
  • Cardinal Health,Medical Products and Services510(k), enforcement report, recall
  • Carefusion 209, Inc.510(k), recall
  • Carefusion 2200, Inc.registration, 510(k), enforcement report, recall
  • Covidien LLCregistration, 510(k), PMA, enforcement report, recall
  • Covidien LLC dba Uni-Patchenforcement report, recall
  • Covidien LP (formerly Nellcor Puritan Bennett Inc.)enforcement report, recall
  • COVIDIEN MEDTRONICenforcement report, recall
  • Ev3 Neurovascular510(k), PMA, recall
  • ev3, Inc.registration
  • Fox Hollow Technologies510(k), recall
  • Kendall a Division of Tyco Healthcare Group LPrecall
  • Kendall Healthcare Products Corecall
  • Kyphon, Inc.510(k), recall
  • Medtronic Ave, Inc.510(k), recall
  • Medtronic CardioVascularrecall
  • Medtronic formerly Covidienenforcement report, recall
  • Medtronic Inc. Cardiac Rhythm Disease Managementenforcement report, recall
  • Medtronic Inc. Cardiac Rhythm Disease Managmentrecall
  • Medtronic Inc. Cardiac Rhythm Managmentrecall
  • Medtronic Inc., Cardiac Rhythm and Heart Failureenforcement report, recall
  • Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)enforcement report, recall
  • Medtronic Minimally Invasive Therapies Groupenforcement report, recall
  • Medtronic Minimed, Inc.registration, 510(k), PMA, enforcement report, recall
  • Medtronic Spine LLC, formerly Kyphon Increcall
  • Medtronic Vascular, Inc.registration, 510(k), PMA, enforcement report, recall
  • Medtronic,Inc/Rice Creek Facilrecall
  • Micro Therapeutics Inc Dba Ev3 Neurovascularregistration, 510(k), enforcement report, recall
  • Micro Therapeutics, Inc.510(k), enforcement report, recall
  • Natus Neurology Incenforcement report, recall
  • Natus Neurology Incorporatedregistration, 510(k), enforcement report, recall
  • Nellcor Puritan Bennett Inc. (dba Covidien LP)enforcement report, recall
  • Nellcor Puritan Bennett, Inc.510(k), PMA, recall
  • Nicolet Biomedical Div of Viasys Healthcarerecall
  • Puritan-Bennett510(k), recall
  • St. Francis Medical Technologies Increcall
  • Superdimension, Ltd.510(k), enforcement report, recall
  • Surgical Devices/Covidienrecall
  • United States Surgical Corporationrecall
  • Valleylab, Inc.510(k), recall

510(k) clearance history

Showing 50 of 1,525

FDA records hold 1,525 510(k) clearances for Medtronic, Inc. between 1976 and 2026. The busiest year on record is 2015, with 55. The most recent is 2026, with 20.

Clearances by year, as a table
510(k) clearance decisions for Medtronic, Inc., by decision year
YearClearances
19762
19775
197833
197930
198016
198127
198217
198313
198415
198534
198633
198729
198826
198935
199041
199146
199233
199325
199434
199530
199631
199736
199829
199939
200040
200139
200237
200347
200437
200522
200631
200723
200824
200927
201035
201128
201247
201339
201443
201555
201652
201732
201830
201925
202030
202121
202223
202324
202420
202515
202620
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260907BIS™ Advance pEEG ModuleOLWSubstantially Equivalent
K261335VitalFlow Set with Balance™ BiosurfaceQJZSubstantially Equivalent
K261962SmartGuard Technology; Predictive Low Glucose TechnologyQJISubstantially Equivalent
K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)GAGSubstantially Equivalent
K261866Concerto Versa™ Detachable CoilKRDSubstantially Equivalent
K253984Instrument Exit Point on Touch Surgery™ AideSFESubstantially Equivalent
K253530Trexon™ Monofilament Synthetic Absorbable SutureGAMSubstantially Equivalent
K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)CCKSubstantially Equivalent
K253243Cardinal Health™ Poly Reinforced Surgical GownFYASubstantially Equivalent
K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeDWFSubstantially Equivalent
K253743MiniMed Flex pumpQFGSubstantially Equivalent
K253203Retrograde Coronary Sinus Perfusion CannulaeDWFSubstantially Equivalent
K253701SmartGuard Technology; Predictive Low Glucose TechnologyQJISubstantially Equivalent
K253998Clearview Intracoronary ShuntsDWFSubstantially Equivalent
K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterDTMSubstantially Equivalent
K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)QFGSubstantially Equivalent
K251831Bio-Medicus Life Support Catheter and IntroducerQHWSubstantially Equivalent
K253585SmartGuard technology; Predictive Low Glucose technologyQJISubstantially Equivalent
K253511Concerto Versa™ Detachable CoilKRDSubstantially Equivalent
K253512MiniMed Go AppNDCSubstantially Equivalent
K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLTJOHSubstantially Equivalent
K251025Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)BZTSubstantially Equivalent
K253409C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)DQYSubstantially Equivalent
K250725Hugo™ RAS SystemSCVSubstantially Equivalent
K250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)BTRSubstantially Equivalent
K243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless ReinforcedBTRSubstantially Equivalent
K251217SmartGuard technology; Predictive Low Glucose technologyQJISubstantially Equivalent
K251032MiniMed 780G insulin pumpQFGSubstantially Equivalent
K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannulaDWFSubstantially Equivalent
K250075Medtronic Stedi Extra Support GuidewireDQXSubstantially Equivalent
K250199VitalFlow ConsoleQNRSubstantially Equivalent
K250558SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)DQYSubstantially Equivalent
K243982Nicolet EDXGWFSubstantially Equivalent
K243892Affera Integrated Mapping SystemDQKSubstantially Equivalent
K242705Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)LDFSubstantially Equivalent
K243495Natus Ultrapro S100 (982A0594)GWFSubstantially Equivalent
K243435Magnetic Localization Patch Kit (AFR-00021)DQKSubstantially Equivalent
K241486Sofsilk™ Coated Braided Silk SutureGAPSubstantially Equivalent
K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))NDCSubstantially Equivalent
K241828Affera Integrated Mapping System; Impedance Localization Patch KitDQKSubstantially Equivalent
K240880VitalFlow Set with Balance BiosurfaceQJZSubstantially Equivalent
K240077Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)FLLSubstantially Equivalent
K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)MTDSubstantially Equivalent
K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)GEISubstantially Equivalent
K241622Extended Reservoir; MiniMed ReservoirLZGSubstantially Equivalent
K240572Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 15’ (4.6m) (VSMP15); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab™ SM Smoke Management Extended Nozzle (for use with 4” (100mm) electrode) (VSMEN4); Valleylab™ SM Smoke Management Extended Nozzle (for use with 6.5” (165mm) electrode) (VSMEN6)GEISubstantially Equivalent
K241352Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)DTZSubstantially Equivalent
K241259Amplatz Goose Neck Snare KitMMXSubstantially Equivalent
K233341Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)BTRSubstantially Equivalent
K240534Bio-Medicus Life Support Catheter and IntroducerQHWSubstantially Equivalent

Registered establishments

FDA registered establishments for Medtronic, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30112003343011200334CARDINAL HEALTH8322 Eagle Palm Drive, Riverview, FL 33578 US2026
16234861623486CARDINAL HEALTH 200, LLC200 MCKNIGHT ST., Jacksonville, TX 75766 US2026
14235073008002452CAREFUSION 2200, INC.75 North Fairway Drive, Vernon Hills, IL 60061 US2026and 54 more, listed in full below
16256851625685CAREFUSION 2200, INC.400 East Foster Rd, Mannford, OK 74044 US2026and 1 more, listed in full below
20245002024500COVIDIEN2101 Faraday Avenue, CARLSBAD, CA 92008 US2026and 6 more, listed in full below
10177681017768Cardinal Health2010 E International Speedway Blvd, DELAND, FL 32724 US2026
10181201018120Cardinal Health1430 Marvin Griffin Rd, AUGUSTA, GA 30906 US2026and 6 more, listed in full below
10339031033903Cardinal Health525 Emerald Rd N, Greenwood, SC 29646 US2026
12191031000148701Cardinal Health2 Ludlow Park Dr, CHICOPEE, MA 01022 US2026and 2 more, listed in full below
19154841915484Cardinal Health1222 SHERWOOD RD., Norfolk, NE 68701 US2026and 3 more, listed in full below
19218461921846Cardinal Health444 JAMES SOUTH MCDONNELL BLVD., Hazelwood, MO 63042 US2026and 156 more, listed in full below
21831641000116809Cardinal Health1313 WEST GRANT BLVD., Wabasha, MN 55981 US2026and 1 more, listed in full below
14235373001236905Cardinal Health 200, LLC3651 Birchwood Drive, Waukegan, IL 60085 US2026and 482 more, listed in full below
30073290203007329020Cardinal Health 200, LLC1320 Don Haskins, El Paso, TX 79936 US2026and 219 more, listed in full below
30123414253012341425Cardinal Health K.K.3033 MOROI, FUKUROI Shizuoka 437-1121 JP2026
12199301219930Covidien60 Middletown Ave, North Haven, CT 06473 US2026and 64 more, listed in full below
17173441717344Covidien6044 Longbow Court, BOULDER, CO 80301 US2026and 1 more, listed in full below
26475802647580CovidienBUILDING 911-67, PONCE, PR 00731 US2026and 17 more, listed in full below
29369992936999Covidien200 Medtronic Dr, Lafayette, CO 80026 US2026and 37 more, listed in full below
30083614983008361498Covidien2800 Airwest Blvd, Suite 160, Plainfield, IN 46168 US2026
30266124813026612481Covidien200 Medtronic Drive, Lafayette, CO 80026 US2026and 1 more, listed in full below
80208933002807850CovidienMichael Collins Road, H91 W9N4 Mervue, - Galway(County) - IE2026and 4 more, listed in full below
96108493002807391CovidienBoulevard Insurgentes 19030 Libramiento, TIJUANA, B.C. Mexico 22225 MX2026and 42 more, listed in full below
96125013003495548CovidienZONA FRANCA DE SAN ISIDRO, - Santo Domingo - DO2026and 55 more, listed in full below
96813843002807626CovidienAvenue Henequen No. 1181, Ciudad Juarez Chihuahua 32573 MX2026and 14 more, listed in full below
12824971282497Covidien LLC15 HAMPSHIRE STREET, MANSFIELD, MA 02048 US2026and 9 more, listed in full below
30049048113004904811Covidien llc3062 Bunker Hill Lane, Santa Clara, CA 95054 US2026
30049627883004962788Covidien llc161 CHESHIRE LANE, Plymouth, MN 55441 US2026and 1 more, listed in full below
20322273003166194MEDTRONIC MINIMED18000 Devonshire St, NORTHRIDGE, CA 91325 US2026and 14 more, listed in full below
12204521220452MEDTRONIC VASCULAR37A Cherry Hill Dr, DANVERS, MA 01923 US2026and 3 more, listed in full below
21822082182208MEDTRONIC, INC.8200 Coral Sea Street NE, Mounds View, MN 55112 US2026and 36 more, listed in full below
30125206543012520654MEDTRONIC, INC.880 Technology Park Drive, Billerica, MA 01821 US2026
20292141000220862MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR9775 Toledo Way, Irvine, CA 92618 US2026and 9 more, listed in full below
30155504513015550451MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR5290 California Avenue, Irvine, CA 92617 US2026and 7 more, listed in full below
29532003001452571Medtronic Vascular3576 Unocal Pl, Santa Rosa, CA 95403 US2026
30015049943001504994Medtronic, Inc.710 Medtronic Parkway, Minneapolis, MN 55432 US2026No device listings on this registration
30041857813004185781Medtronic, Inc.2343 W. Medtronic Way, Tempe, AZ 85281 US2026
30155447463015544746Medtronic, Inc.7000 Central Ave., N.E., Minneapolis, MN 55432 US2026
30106119503010611950Natus Neurology Incorporated3150 Pleasant View Road, Middleton, WI 53562 US2026and 22 more, listed in full below
21838702183870ev3, Inc.4600 Nathan Lane North, Plymouth, MN 55442 US2026and 11 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Showing 25 of 2,578
Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2949-2026Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: SNE12BS01BCardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.Class IIOpen, Classified
Z-2948-2026Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 5) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 6) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLAI; 7) KIT, LAMINECTOMY , Catalog Number: PN41LMB10; 8) KIT, LAMINECTOMY , Catalog Number: PN41LMB11; 9) KIT, LAMINECTOMY , Catalog Number: PN41LMB12; 10) KIT, NEURO LAMINECTOMY , Catalog Number: PN41LMBLC; 11) KIT, BAL CRANIOTOMY , Catalog Number: PNCGCRBMF; 12) KIT,LAMINECTOMY NH , Catalog Number: PNOCLNNHB; 13) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA235; 14) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA236; 15) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA237; 63Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.Class IIOpen, Classified
Z-2947-2026Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2C; 4) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2D; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC2D; 6) KIT, IUS NASAL , Catalog Number: PECGNSBOA; 7) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHB; 8) KIT,ENT , Catalog Number: PEMIEPHP2; 9) KIT,ENT , Catalog Number: PEMIEPHP3; 10) KIT,ENT , Catalog Number: PEMIEPHPB; 11) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL016; 12) KIT, ENT FESS , Catalog Number: PEV2FSNYC;Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.Class IIOpen, Classified
Z-2946-2026Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog Number: SNE30CRJGY; 4) NEURO PACK , Catalog Number: SNE43NEE13; 5) LAMINECTOMY PACK , Catalog Number: SNE43NEE13; 7) LAMINECTOMY PACK , Catalog Number: SNE5CLPB13; 8) PEDI SPINE ROSEVILLE , Catalog Number: SNE69PSKR4; 9) SHUNT PACK , Catalog Number: SNE7CSHY15; 10) SHUNT PACK , Catalog Number: SNE7CSHY16; 11) ENS ORTHO FUSION POSTERIEURE 3, Catalog Number: SOP30ODSCLCardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.Class IIOpen, Classified
Z-2945-2026Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog Number: PE33HNCR2; 9) KIT, HEAD AND NECK , Catalog Number: PE33HNCR3; 10) KIT, HEAD AND NECK , Catalog Number: PE33HNCR4; 11) KIT, HEAD AND NECK , Catalog Number: PE33HNCRA; 12) KIT, HEAD AND NECK , Catalog Number: PE33HNCRB; 13) KIT, NASAL , Catalog Number: PE35NSB23; 14) KIT, NASAL , Catalog Number: PE35NSBLG; 15) KIT, EENT , Catalog Number: PE44EMKW8;Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.Class IIOpen, Classified
Z-2944-2026Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMBCardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.Class IIOpen, Classified
Z-2943-2026Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCCCardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.Class IIOpen, Classified
Z-2942-2026Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 5) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 6) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLH9; 7) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHC; 8) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHD; 9) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHE; 10) KIT,NEURO , Catalog Number: PN21OTMC6; 11) KIT,NEURO , Catalog Number: PN21OTMC7; 12) KIT,NEURO , Catalog Number: PN21OTMCC; 13) KIT,NEURO , Catalog Number: PN21OTMCD; 14) KIT, MER CRANI , Catalog Number: PN33CRMYB; 15) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCHB; 16) KIT, CRANIOTOMY , Catalog Number: PN40CKC27; 17) KIT, CRANIOTOMY , Catalog Number: PN40CKC28; 18) KIT, CRANIOTOMY , Catalog Number: PN40CKC29; 19) KIT, CRANIOTOMY , Catalog Number: PN40CKCFC; 20) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMB; 21) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMC; 22) BASIC PACK , Catalog Number: SBA73BPGCA; 23) FACIAL FEMINIZATION PACK , Catalog Number: SBA73FFKW9; 24) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH6; 25) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH7; 26) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHH8; 27) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHF; 28) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHG; 29) EDGECOMBE BASIC MILLER PACK , Catalog Number: SBA95BMHHH; 30) TRAM PACK , Catalog Number: SBA95TPD10; 31) TRAM PACK , Catalog Number: SBA95TPD11; 32) TRAM PACK , Catalog Number: SBA95TPDU6; 33) TRAM PACK , Catalog Number: SBA95TPDU7; 34) TRAM PACK , Catalog Number: SBA95TPDU8; 35) TRAM PACK , Catalog Number: SBA95TPDU9; 36) TRAM PACK , Catalog Number: SBA95TPDUP; 37) TRAM PACK , Catalog Number: SBA95TPDUQ; 38) PLASTIC SURGERY PACK ,Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.Class IIOpen, Classified
Z-2982-2026MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLWLoaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.Class IIOpen, Classified
Z-2981-2026MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.Class IIOpen, Classified
Z-2980-2026MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.Class IIOpen, Classified
Z-2922-2026Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GXProduct may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.Class IIOpen, Classified
Z-2921-2026Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.Class IIOpen, Classified
Z-2920-2026Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.Class IIOpen, Classified
Z-2919-2026V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003 BOX08767V1 BOX GASTRIC BYPASS JAWBYPASS2 BOX GASTRIC BYPASS SIGNIA BOX02191V11 BOX GASTRICBYPASS KIT V4 BOX06863V4 BOX GB BOX MET LHOOK PST04884V3 BOX GB ZONDER ENDOHERNIA EGIA PST04884V6 BOX GBP SIGNIA BOX08506V2 BOX KIT COLON IHS KIT00625V1 BOX KIT HERNIA HIATO IHS KIT01026V1 BOX LAP HERNIE INGUNIAL RIGHT BOX00051V4 BOX NEW GBP KIT PST03130V2 BOX ZESTAW DO BARIATRII GB UCKGB5 BOX ZESTAW DO RYGB WEJRYGB3 VLOCL0013 V-LOC* 180 4-0 CLR 30CM P12 VLOCL0013 VLOCL0014 V-LOC* 180 3-0 CLR 30CM P12 VLOCL0014 VLOCL0023 V-LOC* 180 4-0 CLR 45CM P12 VLOCL0023 VLOCL0024 V-LOC* 180 3-0 CLR 45CM P12 VLOCL0024 VLOCL0306 V-LOC 180 DEVICE 0 15CM GS-21 VLOCL0306 VLOCL0316 V-LOC* 180 0 GRN 30CM GS21X12 VLOCL0316 VLOCL0345 V-LOC* 180 2-0 GRN 23CM GS21 VLOCL0345 VLOCL0436 V-LOC* 180 0 GRN 60CM GS25X12 VLOCL0436 VLOCL0604 V-LOC* 180 3-0 GRN 15CM V20 VLOCL0604 VLOCL0615 V-LOC* 180 2-0 GRN 30CM V20 VLOCL0615 VLOCL0625 V-LOC* 180 2-0 GRN 45CM V20 VLOCL0625 VLOCL0644 V-LOC* 180 3-0 GRN 23CM V20 VLOCL0644 VLOCL0804 V-LOC 180 3-0 GRN 15CM CV23 VLOCL0804 VLOCL2105 V-LOC* 180 2-0 GRN 15CM GS22 VLOCL2105 VLOCL2145 V-LOC* 180 2-0 GRN 23CM GS22 VLOCL2145 VLOCL2246 VLOC180 0 GRN 9 GS-22 VLOCL2246Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.Class IIOpen, Classified
Z-2918-2026V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12 VLOCM0013 VLOCM0024 V-LOC* 90 3-0 CLR 45CM P12X12 VLOCM0024 VLOCM0123 V-LOC* 90 4-0 CLR 45CM P14X12 VLOCM0123 VLOCM0315 V-LOC* 90 2-0 VIO 30CM GS21 VLOCM0315 VLOCM0603 V-LOC* 90 4-0 VIO 15CM V20X12 VLOCM0603 VLOCM0604 V-LOC* 90 3-0 VIO 15CM V20X12 VLOCM0604 VLOCM1203 V-LOC* 90 4-0 VIO 15CM CV15 VLOCM1203 VLOCM2115 V-LOC* 90 2-0 VIO 30CM GS22 VLOCM2115Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.Class IIOpen, Classified
Z-2778-2026MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.Class IIOpen, Classified
Z-2774-2026Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.Class IIOpen, Classified
Z-2773-2026Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.Class IIOpen, Classified
Z-2698-2026MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA).Class IIOpen, Classified
Z-2950-2026EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures.Class IIOpen, Classified
Z-2273-2026Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050Temperature probe devices lack FDA clearance.Class IIOpen, Classified
Z-2272-2026Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044Temperature probe devices lack FDA clearance.Class IIOpen, Classified
Z-2271-2026Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042Temperature probe devices lack FDA clearance.Class IIOpen, Classified
Z-2653-2026Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884522006613 6DCFS 10884522006620 6DFEN 10884522006644 8DCFN 10884522006651 8DCFS 40884522006690 8DFEN 10884522006675 10DCFN 20884522006535 10DCFS 10884522006545 10DFEN 10884522006569 The Shiley Disposable Decannulation Plug (DDCP) is a universal size and fits any size DCFS, DCFN, DFEN tracheostomy tube. The red DDCP snaplock connector is used to occlude the proximal end of the outer cannula on the Shiley Tracheostomy Tubes. Refer to Table 1 for model types. The DDCP blocks airflow through the tube and directs breathing through the mouth and nose. The Shiley Tracheostomy Tube and the accessory products are intended for use in providing tracheal access for airway management.Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.Class IIOpen, Classified

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