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 1693 of 3531
510(k) clearances, page 1693 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K993754Hsv-1 Elisa Igg, Model El0910gMrl DiagnosticsMXJClass II
K992979Shanghai Poseidon Powder-Free Synthetic Vinyl Examination Gloves, YellowShanghai Poseidon Plastic Products Co., Ltd.LYZClass I
K992930Bioteque Hemodialysis Blood Tubing SetBioteque Corp.FJKClass II
DEN000002Urosurge Percutaneous Sans (Stoller Afferent Nerve Stimulator) DeviceUrosurge, Inc.NAMClass II
K994336Bitx ProbesEverest Medical Corp.GEIClass II
K994262Frontal Sinus Trephination CannulaXomed, Inc.KAMClass I
K994191Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754TNmt Medical, Inc.HCIClass II
K994177Sutrasilk Silk SutureVisionary Medical Supplies, Inc.GAPClass II
K994176Sutralon Nylon SuturesVisionary Medical Supplies, Inc.GARClass II
K994172Cerec 3Sirona Dental Systems GmbHELWClass II
K993818Antegrade/retrograde Perfusion Adapter with or without Pressure LineCalifornia Medical Laboratories, Inc.DWFClass II
K992739Click'xSynthes GmbHMNHClass II
K000153Arthro-Surgimat-A103Novanta Medical GmbHHRXClass II
K000102Glucose (Hexokinase) Liquid Reagent, Model G518-150Teco DiagnosticsCFRClass II
K000094Modification to Cd Horizon Spinal SystemMedtronic Sofamor Danek USA IncMNHClass II
K994304Arabesk FlowVoco GmbHEBFClass II
K994302Resin Tooth Bonding AgentParkell, Inc.KLEClass II
K994255Latex Examination Gloves-Pre-Powdered-SterileP.T. Maja Agung LatexindoLYYClass I
K994250Tekmedic Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)Tekmedic (M) Sdn BhdLYYClass I
K994222Sensi-Pro Disposable Powder Free Vinyl Synthetic Examination Gloves, Beige ColorShijiazhuang Hongray Plastic Products Co., Ltd.LYZClass I
K994206Sensi-Pro Disposable Powdered Vinyl Synthetic Examination Gloves, Beige ColorShijiazhuang Hongray Plastic Products Co., Ltd.LYZClass I
K994201Rubbercare Powder-Free, Guardian Powder-Free Latex Exam Gloves with Protein Labeling Claim (50 Micrograms or Less)Perusahaan Pelindung Getah (M) Sdn BhdLYYClass I
K994131Ambiderm Powderfree Latex Examination Gloves with a Protein Claim of 50 Micrograms or Less per Gram (Black Colored)Medtaxx PartnersLYYClass I
K993972Disposable Infusion Pump KitZimmer GmbHMEBClass II
K993876Powder-Free Nitrile Examination Gloves with Aloe VeraShen Wei (USA), Inc.LZAClass I
K993804Ksea Rigid Culdoscope and AccessoriesKarl Storz Endoscopy-America, Inc.HEWClass II
K993801Gynecare Laparoscopic MorcellatorEthicon, IncHETClass II
K993794Platex Oder Absorbing Gentle Glide, Slimfits and Silk Glide TamponsPlaytime Products, Inc.HEBClass II
K992854Artificial Teeth (Acrylic Teeth)Masterdent, LtdaELMClass II
K992815The Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd.MEHClass II
K991392Human Serum AlbuminAdvanced Reproductive TechnologiesMQLClass II
K000254Par 5 Acetabular ComponentZimmer GmbHJDIClass II
K000149Novabone-Bioglass Bone Graft ParticulateUsbiomaterials Corp.LYCClass II
K993803Excelart with PianissimoToshiba America Mri, Inc.LNHClass II
K994438Bilichek Non-Invasive Bilirubin AnalyzerSpectrx, Inc.MQMClass I
K994383Dogbone AcfsTheken Surgical,LlcKWQClass II
K994315Cp Peripheral Angio Array Coil/ Magnetom Symphony SystemSiemens Medical Solutions USA, Inc.MOSClass II
K994294Dimension Trnf Flex Reagent CartridgeSiemens Healthcare Diagnostics Inc.DDGClass II
K994211Acucam Intraoral Camera Sheaths, Models 023545, 601111, 300407, 601285Dentsply Intl.KKXClass II
K994210Inturis SuitePhilips North America LLCLLZClass II
K994160Coalescent Surgical Sutured-ClipCoalescent SurgicalFZPClass II
K994117Mr EnhancerI.Z.I. Corp.LNHClass II
K994090Karl Storz Autoclavable Camera HeadKarl Storz Imaging, Inc.FETClass II
K994007Mallory/head Smooth Femoral ComponentZimmer GmbHJDIClass II
K994002Plain/chromic CatgutTrading Consultants and Distributors Intl., Inc.GALClass II
K994000PolyesterTrading Consultants and Distributors Intl., Inc.GATClass II
K993999SilkTrading Consultants and Distributors Intl., Inc.GAPClass II
K993998NylonTrading Consultants and Distributors Intl., Inc.GARClass II
K993997PolypropyleneTrading Consultants and Distributors Intl., Inc.GAWClass II
K993943Encore Linear Porous Coated Hip with Ha, Encore Foundation Porous Hip with Ha, Encore Revelation Porous Hip with HaEncore Orthopedics, Inc.MEHClass II