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 2276 of 3531
510(k) clearances, page 2276 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K930407Powder-Free Latex Examination GlovesInflux Pacific Sdn. Bhd.LYYClass I
K930109Komet Medical Surgical Power AccesoriesBrassler USAJDXClass II
K926465Femoral Intramedullary RodsApplied Osteo Systems, Inc.JDSClass II
K926451Datascope Multinex IIDatascope Corp.CBQClass II
K924390Angemed 5000 Lead AdapterAngemed, Inc.LDFClass II
K924050Titanium Nitride Coated Hemi-Head ComponentOrthomet, Inc.KWLClass II
K914802Datascope Percor Stat Dl9.5 Fr34cc Intra-Aort BallDatascope Corp.DSPClass II
K913831Vasco Tip/vascoflangeVascor Medical Corp.DTBClass III
K911000Percor Stat Dl 8.5 Fr 40Cc Intra-Aortic BalloonDatascope Corp.DSPClass II
K933520Endoscopic Anti-Fog Kit, 100-302-00Avail-Southwest DivisionGCJClass II
K933238Rotablator, ModificationHeart Technology, Inc.MCWClass II
K933049Srugical Retractor, ModificationAdvanced Surgical, Inc.GCJClass II
K932920Glenroe Plastic BracketGlenroe TechnologiesDYWClass II
K932619Transseptal Introducer SetMerit Medical Systems, Inc.DQYClass II
K931710Pulpdent Dental Bond Enhancer 2-BPulpdent CorporationKLEClass II
K931632I.d.a. SyringesPt Hasoon ChandraFMFClass II
K931492Lapra-Ty* Suture ClipEthicon, IncFZPClass II
K930405Bisco D/c Core CompositeBisco, Inc.EBFClass II
K930336Profast(r)-Denture Adhesive CreamFittydent-Altwirth & Schmitt GmbHKGBClass I
K930139Hypo-Allergenic Patient Examination GlovesShun Thai Rubber Gloves Industry Co., Ltd.LYYClass I
K926526Latex Examination Gloves (Powder Free)Rantran, Inc.LYYClass I
K926464L.c.s.3000Cryodyne Technologies, Inc.GEHClass II
K926413Medtronic Arterial FilterMedtronic, Inc.DTMClass II
K925967MedcamMedcam USA, Inc.EIAClass I
K925900Lacey Revision Femoral ComponentDow Corning WrightJWHClass II
K925741Clarus Endoscopic Hook KnifeClarus Medical Systems, Inc.HLXClass II
K924034Minvasive Suture Bone FastenerInnovasive Devices, Inc.JDRClass II
K921481Interference-Cannu-Flex/silk Screws-Screw Dr/g WirAcufex Microsurgical, Inc.HWCClass II
K914121Vascoscrew 6/60 and Vascoscrew 8/60Vascor Medical Corp.DTBClass III
K933644Widex Model Logo 8 (L8)Widex Hearing Aid Co., Inc.ESDClass I
K933643Widex Model Logo 6 (L6)Widex Hearing Aid Co., Inc.ESDClass I
K933640Widex Model Logo 12 (L12)Widex Hearing Aid Co., Inc.ESDClass I
K933579Memorex Artisan System/artisan Programmer and Custom Hearing AidTelex Communications, Inc.ESDClass I
K933447Stenoscop Mobile Fluoroscopic XRAY SystemGE HealthcareOXOClass II
K933307Multifocus Compact Bte Hearing AidOticon, Inc.ESDClass I
K933291Maico Bte Model Rd-111 and Ite Model Rd-312 Hearing AidMaico Hearing Instruments, Inc.ESDClass I
K933123Synelisa Tg Antibodies/tpo AntibodiesElias U.S.A., Inc.JZSClass I
K932679Rheumelisa II Histone Antibody Test KitBiowhittaker Molecular Applications, Inc.LKJClass II
K932437Eye Spot RF TestJ & S Medical Assoc., Inc.DHRClass II
K932302Sylnelisa Histone AntibodiesElias U.S.A., Inc.LKJClass II
K932273Cordis TunnelerCordis US Corp.GYKClass I
K932180Eye Spot Crp TestJ.S. Medical Assoc.DCNClass II
K932030Coulter Stks with Reticulocyte Analysis CapabilityCoulter Corp.GKZClass II
K931956Cascade M, Cat. No. 1710Helena Laboratories, Corp.GKPClass II
K931883Ax-390Se Automatic X-Ray Film Processor 9586.033Alphatek Corp.IXWClass II
K931882Mammo-300 Automatic X-Ray Film ProcessorAlphatek Corp.IXWClass II
K9318152000 X-Ray - TomographicDental Imaging Technologies CorporationIZFClass II
K931780Methadone Metabolite Eia AssayDiagnostic Reagents, Inc.DJRClass II
K931563Spectrum Mark I Special Procedures TableSpectrum X-Ray Corp.IXRClass II
K931206Electra 1600C Automatic Coagulation TimerMedical Laboratory Automation Systems, Inc.GKPClass II