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 2360 of 3531
510(k) clearances, page 2360 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K922638Tempit-ECentrix, Inc.EMAClass II
K922318Douglas Medical Products, Inc. Irrigation SetDouglas Medical Products, IncHRXClass II
K922212Mdt Castle Biosign Test PackMdt Corp., Inc.FRCClass II
K922143American Burn SheetAmerican Silk Sutures, Inc.KMEClass I
K922055Sterile and Non-Sterile Gauze SpongesTeam Mfg., Inc.EFQUnclassified
K922054Sterile Gauze Sponges X-Ray DetectableTeam Mfg., Inc.GDYClass I
K921760TricoplastBeiersdorf, Inc.KGXClass I
K921759AcrylasticBeiersdorf, Inc.KGXClass I
K921564PolycleanMedical Polymers, Inc.EFBClass I
K921538AmalgaphaseSaskan Amalgam Alloys, Inc.EJJClass II
K920794Brnd Skin Protection Prep Series 33Xx3M CompanyKMFClass I
K920256Spine Motion Analyzer with EMGMizuho Orthopedic Systems IncKQXClass I
K911575Anchor Implant Dental AttachmentsAnchor Implant Systems, Inc.DZEClass II
K910992Amk Total Knee System W/du Pont Enhanced UhmwpeDepuy, Inc.JWHClass II
K922719Williams Advantage Elevation TableWilliams Manufacturing Co.INQClass I
K922544Medicam 900 Autoelectronic Light SourceKirschner Medical Corp.FSTClass II
K922240Electronic Photospot 20Toshiba America Medical Systems, In.CJAAClass II
K922192Vas DilatorCook IncorporatedKOAClass I
K921719Acs Angiotrak(tm) SystemAdvanced Cardiovascular Systems, Inc.MAVClass II
K921672Inter-Ha Hip ProsthesisKirschner Medical Corp.MEHClass II
K921484MedvisionEvergreen Technologies, Inc.LLZClass II
K920958Summit Nuclear Vision NeurospectSummit NuclearKPSClass II
K920396Kirschner Performance Total Knee SystemKirschner Medical Corp.JWHClass II
K915566Disetronic Panomat PumpDisetronic Medical SystemsFRNClass II
K914675Modular Femoral Head with Offset TrunionKirschner Medical Corp.JDIClass II
K923491Bte Hearing Aid Personic 425Oticon, Inc.ESDClass I
K923490Bte Hearing Aid Personic 410Oticon, Inc.ESDClass I
K923388Bte Hearing Aid Oticon Model: Multifocus PowerOticon, Inc.ESDClass I
K923291Naico Wheel ChairsNaico Corp.IORClass I
K923159Arjo-Century Podiatric Whirlpool SystemsArjo-Century, Inc.ILJClass II
K922739Hollister Horizontal Drain/tube Attachment DeviceHollister, Inc.GBXClass I
K922633Cavi-ZymeE&D Dental Products, Inc.EJBClass I
K922570Resound Personal Hearing System Soundlink-1Resound Corp.EPFClass II
K922186Hem-O-Lok -- ModificationLinvatec CorporationGDWClass II
K922175Healthpak Chair Sox BarriersHealthpak, Inc.KLCClass I
K922167Alphatec Compression and Reconstruction PlatesAlphatec Spine, Inc.HRSClass II
K922166Alphatec Small Fragment SetAlphatec Spine, Inc.HWCClass II
K921253Instrument Irrigation PumpPsi Medical Products, Inc.KODClass II
K921165Bair Hugger Torso Blanket - Arms in Model 540Augustine Medical, Inc.DWJClass II
K921053Laparomed Ligating LoopLaparomed Corp.KCJClass I
K920752Endopath Ils Endoscopic Circular StaplerEthicon, IncGDWClass II
K920356Surgical SpongesUltracell Medical Technologies, Inc.GDYClass I
K920355Specialty SpongesUltracell Medical Technologies, Inc.GDYClass I
K920105ScalamobilAlber Technologies, Inc.INGClass II
K913303Lap Sponges, ModifiedCarwild Corp.GDYClass I
K923306Healthpak Utility Sox BarriersHealthpak, Inc.KLCClass I
K922854Aqua MeronVoco GmbHEMAClass II
K922823Access Theophylline Immunoassay ReagentsBio-Rad Laboratories Inc.CGNClass II
K922451Legacy-XtJ.F. Jelenko & Co., Inc.EJSClass II
K922450Benchmark CJ.F. Jelenko & Co., Inc.EJSClass II