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Applied Medical Resources Corp

Rsm, CA, US

APPLIED MEDICAL RESOURCES CORP. appears in FDA device records in Rsm, CA. FDA records list 115 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 75 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
115
PMA records
0
Recall records
75
Registered establishments
1

510(k) clearance history

Showing 50 of 115

FDA records hold 115 510(k) clearances for Applied Medical Resources Corp between 1992 and 2026. The busiest year on record is 1993, with 11. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Applied Medical Resources Corp, by decision year
YearClearances
19921
199311
19948
19957
19963
19975
19982
19997
20001
20015
20024
20034
20045
20066
20073
20081
20092
20103
20111
20131
20144
20153
20164
20172
20185
20193
20202
20212
20223
20231
20254
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260982Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)KGWSubstantially Equivalent
K253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)KGWSubstantially Equivalent
K252740Voyant® Open Fusion Device (EB240/Open Fusion)GEISubstantially Equivalent
K252442Kii Structural Balloon Access SystemGCJSubstantially Equivalent
K252412Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)GEISubstantially Equivalent
K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceHEWSubstantially Equivalent
K232880Inzii Ripstop Redeployable Retrieval SystemGCJSubstantially Equivalent
K222284Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)GEISubstantially Equivalent
K220969GelPOINT V-Path Vaginal Access SystemMOKSubstantially Equivalent
K211043Alexis Contained Extraction SystemGCJSubstantially Equivalent
K202049Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterDXESubstantially Equivalent
K200021Applied Medical AnoscopeFERSubstantially Equivalent
K201212Voyant Open Fusion DeviceGEISubstantially Equivalent
K200598Voyant Maryland Fusion DeviceGEISubstantially Equivalent
K193292Voyant 5mm Fusion Device, Voyant Maryland Fusion DeviceGEISubstantially Equivalent
K190331Applied Medical Laparoscopic Linear CutterGDWSubstantially Equivalent
K191294Transvaginal Access PlatformHEWSubstantially Equivalent
K182653Voyant Maryland Fusion DeviceGEISubstantially Equivalent
K182244Voyant Electrosurgical GeneratorGEISubstantially Equivalent
K182024Dissecting Balloon SystemGCJSubstantially Equivalent
K180699Voyant Open Fusion DeviceGEISubstantially Equivalent
K172624Voyant 5mm Fusion DeviceGEISubstantially Equivalent
K171684Epix Electrosurgical Probe with Smoke EvacuationGEISubstantially Equivalent
K171701GelPOINT Path Transanal Access PlatformFERSubstantially Equivalent
K162676Voyant Open Fusion DeviceGEISubstantially Equivalent
K153017Voyant Fine FusionGEISubstantially Equivalent
K153288Voyant Open Fusion DeviceGEISubstantially Equivalent
K151480Epix Electrosurgical Probe with Smoke EvacuationGEISubstantially Equivalent
K143308GelPOINT Transvaginal Access PlatformHEWSubstantially Equivalent
K143536Voyant Fine Fusion DeviceGEISubstantially Equivalent
K143517Voyant Open Sealer-Divider DeviceGEISubstantially Equivalent
K142427TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25GCJSubstantially Equivalent
K141288VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICEGEISubstantially Equivalent
K132300EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, REGEISubstantially Equivalent
K133393GELPOINT PATH TRANSANAL ACCESS PLATFORMFERSubstantially Equivalent
K113268ALEXIS O WOUND PROTECTOR/RETRACTORKGWSubstantially Equivalent
K110792GELPOINT PATHFERSubstantially Equivalent
K103282LAPAROSCOPIC DISSECTORGEISubstantially Equivalent
K100959SPECIMEN RETRIEVAL SYSTEMGCJSubstantially Equivalent
K100120ALEXIS ORTHOPAEDIC WOUND RETRACTORKGWSubstantially Equivalent
K093296ALEXIS LAPAROSCOPIC SYSTEMKGWSubstantially Equivalent
K090275GELPORT SINGLE INCISION ACCESS SYSTEMGCJSubstantially Equivalent
K083638FIXATION TROCARSGCJSubstantially Equivalent
K072674KII TROCAR SYSTEMGCJSubstantially Equivalent
K063658INTRAVASCULAR INTRODUCER SYSTEMDYBSubstantially Equivalent
K062907ALEXIS WOUND RETRACTORKGWSubstantially Equivalent
K062169APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORSHETSubstantially Equivalent
K060629GELPORT BLUNT TIP TROCAR SYSTEMGCJSubstantially Equivalent
K060673PEDIATRIC URETERAL STENTFADSubstantially Equivalent
K060534INTUITIVE SURGICAL SEALGCJSubstantially Equivalent

Registered establishments

FDA registered establishments for Applied Medical Resources Corp, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20271112027111APPLIED MEDICAL RESOURCES CORP.22872 AVENIDA EMPRESA, RSM, CA 92688 US2026and 20 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 75
Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1010-2026Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.Class IIOpen, Classified
Z-1389-2024Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - HPATECTOMIE ERASME, GK1011, K-19459, GK1014, K-18031 STANDARD KIT, GK1018, K-20735 STANDARD KIT, GK1033, AME STANDARD KIT 21-023, GK1044, KE39830 COLE, GK1047, AME STANDARD KIT 22-003, GK1063, AME STANDARD KIT 22-022, GK1068, AME STANDARD KIT 22-027, GK1071, AME STANDARD KIT 22-030, GK1083, AME STANDARD KIT 22-045, GK1094, AME STANDARD KIT 23-015, GK1096, AME STANDARD KIT 23-017, GK1101, AME STANDARD KIT 23-033, GK131, LAP CHOLE PROCEDURE PACK, GK153, TOTAL 5mm SOLUTION KIT 11, GK168, 10mm ACCESS/LIGATION/RETRIEVAL PK, GK258, AME STANDARD KIT 44, GK260, STANDARD SET 360 Z, GK307, CHOLE KIT 1, GK308, CHOLE KIT 15, GK320, CHOLE KIT 24, GK358, CHOLE KIT 22, GK360, CHOLE KIT 18, GK363, CHOLE KIT 31, GK364, CHOLE KIT 30, GK365, CHOLE KIT 28, GK368, CHOLE KIT 33, GK401, TOTAL 5mm SOLUTION KIT 41, GK402, TOTAL 5mm SOLUTION KIT 42, GK736, LAP. CHOLECYST. CLIP, GK738, STANDARD SET 112 F, GK739, STANDARD SET 397 F, GK834, K100796, GK835, KIT AME 55003, GK837, KIT K86656, GK857, KIT CHOLECYSTECTOMIE LOBBES, GK858, KIT KE284, GK861, KIT VESICULE 11MM CHA, GK874, LAP CHOLE KIT Z-THREAD, GK877, LAP CHOL KIT 5, GK878, SSMC LAP, CHOLE, KIT NO.1, GK879, SSMC LAP, CHOLE, KIT NO. 2, GK891, LAP-GALLE-SET, GK895, KIT HERES LAP CHOL 5MM, GK905, GALLKIT TORSBY SJUKHUS, GK920, K57569, GK921, K57526, GK924, K65251, GK962, LAP CHOL BOOM, GK965, URO- VARIKOCELEN+LYMPHEKTOMIESET, GK969, KIT LAP CHOL TOORENVLIET, GK980, KE78892 LAP PROSTATECTOMY 2, GK983, KIT KE 111515, GK987, LAP. CHOLE-SET LKH MURTAL, GK988, LAPCHOLE KIT ERASME VERSION 4, GK992, K8056 - KIT COLE, GK993, K116634, GK998, GALLEKIT VOSS, JK001, OLYMPUS KIT 1 (2XCTF03,1XCA500), JK003, OLYMPUS KIT 3 (2XCFF05, 1XCA500), JK004, OLYMPUS KIT 4 (2XCTR05, 1XCA500), K0880, DR. THAMES-LAP CHOLE, K0924, DR. COMPTON'S LAP CHOLE PACK, K2212, DR. MILLER LAP CHOLE KIT, K2440, LAP CHOLE KIT, K2607, BORLAND GASTRIC SLEEVE, K2640, LAP CHOLE KIT, K2656, SOUTH SUNFLOWER LAP CHOLE KIT, K2703, DR. AZAR LAP CHOLE PACK, K2705, DRS.GIROD & INGRAM LAP CHOLE PACK, K2797, LAP CHOLE PROCEDURAL PACK 1, K2903, LAP CHOLE KIT, K2922, KIT CLIP APPLIER, K2924, CLIP KIT A, K2925, CLIP KIT F, K2926, CLIP KIT F, K2927, CLIP KIT B, K2928, LAP CHOLE KIT, K2929, LAP CHOLE KIT, K2933, AM MENAT KIT # 0001, K2934, AM MENAT KIT # 0002Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.Class IIOpen, Classified
Z-1388-2024Epix Universal Clip Applier, REF: CA500, STERILEEOTheir is the potential that Universal Clip applier may not load clip after the trigger is actuated.Class IIOpen, Classified
Z-2161-2020Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.Class IITerminated
Z-2160-2020DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.Class IITerminated
Z-2159-2020Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.Class IITerminated
Z-2158-2020Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.Class IITerminated
Z-2037-2020STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.Failure of cardiovascular clips to provide sufficient occlusion of the vessel.Class IITerminated
Z-2036-2020STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.Failure of cardiovascular clips to provide sufficient occlusion of the vessel.Class IITerminated
Z-2035-2020STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.Failure of cardiovascular clips to provide sufficient occlusion of the vessel.Class IITerminated
Z-2034-2020STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.Failure of cardiovascular clips to provide sufficient occlusion of the vessel.Class IITerminated
Z-1848-2020Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.Class ITerminated
Z-1847-2020Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X; CE0680DR/(01)H699CE0680DR10YThe firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.Class ITerminated
Z-1846-2020Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.Class ITerminated
Z-1959-2019Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.Class IITerminated
Z-0510-2020GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.Unintentional shifting of the tip insulation of the firm's electrosurgical probes.Class IITerminated
Z-0509-2020Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1 - Product Usage: The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic surgical procedures where the device is introduced into the body through a cannula. The device may be used for the evacuation of smoke created by electrosurgery at the surgical site.Unintentional shifting of the tip insulation of the firm's electrosurgical probes.Class IITerminated
Z-2533-2017Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.Due to possibility of insufficient sterilization.Class IITerminated
Z-1621-2016Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.Class IITerminated
Z-1332-2016STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.Class IITerminated
Z-1331-2016STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.Class IITerminated
Z-1330-2016STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.Class IITerminated
Z-1329-2016CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.Class IITerminated
Z-2769-2015Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm (EB040) in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The system delivers the energy required to fuse the tissue between the jaws of the device by monitoring voltage and current throughout the seal cycle. The device also features a useractuated blade for the transection of sealed tissue.Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.Class IITerminated
Z-0183-2014Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.Applied Medical is conducting a voluntary recall of the Inzii 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. The likelihood of this situation to occur and result in patient harm is highly unlikely; however, out of an abundance of caution for patient safety and a commitmenClass IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain