510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of , the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years
46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.
Show the numbers
510(k) clearances by decision year, the last 15 years of ingested records
YearClearances
20123,135
20133,052
20143,202
20153,020
20162,956
20173,200
20183,062
20192,918
20202,923
20213,023
20223,209
20233,346
20243,129
20253,225
20262,732
176,529 records, page 2063 of 3531
510(k) clearances, page 2063 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K952189Med-Tec RedisetMedtec LLCIYEClass II
K951471Strickland Trapezial ImplantWrightmedicaltechnologyincKYIClass II
K951291Osteonics Restoration Monolithic Hip StemOsteonics Corp.MEHClass II
K945730Signa ProfileGE HealthcareLNHClass II
K945374Acu-HaltEva-Health USA, Inc.LDQ
K943189Medrad Qwik-Fix MRI Disposable KitMedrad, Inc.LNHClass II
K941098Secure-SiteOp-Co Medical Products, Ltd.KMKClass I
K936008Duracon BaseplatesHowmedica Corp.JWHClass II
K934552PeripumpDeschutes Medical Products, Inc.HIRClass II
K953226Pulm O2 Suction Catheter TraysPremium Plastics, Inc.BSYClass I
K953169Stelkast All Polyethylene Acetabular CupGlobus Medical, Inc.LZOClass II
K953071Stryker Command2 Office ConsoleStryker Corp.JEAClass I
K952734Hennert SaHennert S.A.HQYClass I
K952568Beckman Array Tobramycin (Tob) ReagentBeckman Instruments, Inc.LCRClass II
K952100Rusch Endotracheal Tube StyletRusch, Inc.BSRClass I
K951314Truefill Pva ParticlesCordis Neurovascular, Inc.HCGClass II
K951290Axsym SalicylateAbbott MedicalDKJClass II
K951273Buxton Built Sterilizer, Buxton Built Reconditioned SterilizerBuxton Medical Servic Corp.FLEClass II
K950910Transit-2 Infusion CatheterCordis Neurovascular, Inc.DQOClass II
K946088Genesis Posterior Stabilized (P/s) Knee SystemSmith & Nephew Richards, Inc.JWHClass II
K945229Arrow Multipolar Intracardiac Electrode CathetersArrow Intl., Inc.DRFClass II
K953473Sunglasses (Non-Prescription)Cbi Dist.HQYClass I
K953450Curasol Gel Wound DressingDPT Laboratories, Ltd.MGQUnclassified
K953413Optx 20/20Neoptx, Inc.HQYClass I
K953299PolykoteIntl. Trade Management Co.LYYClass I
K953079LimelightPulpdent CorporationEJKClass II
K953078Storz Dp4101 Basic I/a PackStorz Instrument Co.HQCClass II
K953064Bioaccess Marrow Harvest SystemBioaccess, Inc.GDMClass I
K952986Spi-Secret Personal Instrument CicMidwest City Hearing Aid CenterESDClass I
K952939Royal FlashRoyal Flash Enterprise Co., Ltd.HQYClass I
K952907Ex-111 Wound DressingVariseal Manufacturing Corp.FROUnclassified
K952758Gouverneur AudigierEts Gouverneur-AudigierHQYClass I
K952747Lactate Dehydrogenase Reagent SystemMedical Diagnostic Technologies, Inc.CFJClass II
K952744Alanine Aminotransferase Reagent SystemMedical Diagnostic Technologies, Inc.CKAClass I
K952664Solution Administration SetDistronic Sterile Products, Inc.FPAClass II
K952617Bio-OssGeistlich Pharma AGLYCClass II
K952546Silon Silicone Textile CompositeBio Med Sciences, Inc.MDAClass I
K952471Biofix Bioabsorabable Self-Reinforced Poly-L-Lactide, Threaded Fixation RodBioscience, Inc.MAIClass II
K952449Transan, Transparent Film Dressing, Transparent Wound DrssingMedical Device Development Co.MGPUnclassified
K952444Spacemaker Surgical Balloon Dissector with Cannula & the Spacemaker II Surgical Balloon Dissector with CannulaAdjacent Surgical, Inc.GCJClass II
K952426Magnesium ReagentSchiapparelli Biosystems, Inc.JGJClass I
K952407Redi Nurse System (Rns) Pre-Filled 10Cc, 30Cc, 60Cc Syringe W/sterile WaterContour Fabricators of Florida, Inc.KYZClass I
K952406Redi Nurse System (Rns) Pre-Filled 60Cc Irrigation Syringe W/sterile Sodium Chloride SolutionContour Fabricators of Florida, Inc.KYZClass I
K952392Mli SetMedical Technologies of GeorgiaFPAClass II
K952369Krd Pl 2000 Controlled Passive Motion (Cpm) PortablePhysicians Consulting, Inc.BXBClass I
K952278The Reusable Spacemaker Surgical Balloon Dissector & CannulaGeneral Surgical InnovationsGCJClass II
K952241Protouch OvergloveCottrell, Ltd.MMPClass II
K952118ElmerBiological Technology Corp.GEXClass II
K951741Replica Total Hip SystemOsteo-Technology Intl., Inc.LPHClass II
K951512Precise Hospital Foam Cleaner DisinfectantCaltech Industries, Inc.LRJClass I