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 1638 of 3531
510(k) clearances, page 1638 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K002991Zap Dual Curing LightSoft-Core Texas, Inc.EBZClass II
K002916Surgi-Vision Prostate CoilSurgi-Vision, Inc.MOSClass II
K002714Wartner Wart Removal SystemWartner Medical ProductsGEHClass II
K002708Kavo Corund Handpiece 2013Kavo AmericaKOJClass II
K002288Arndt Pediatric Endobronchial BlockerCook Inc.CBIClass II
K002262Diamedix Is-Hsv 1&2 Igm Test SystemDiamedix Corp.LGCClass II
K002064Comfit Chemo Plus Powder Free Blue Nitrile Examination Gloves, Non Sterile (Tested for Use with Chemotherapy Drug) LabelWRP Asia Pacific Sdn BhdLZAClass I
K003488Synchron ControlSiemens Healthcare Diagnostics Inc.JJYClass I
K003414Varelisa Tg (Thyroglobulin) Antibodies,Pharmacia & Upjohn Company LLCJZOClass II
K003359Coloscreen-EsHelena Laboratories, Corp.KHEClass II
K003093Alkaline Phosphatase-Sl Assay, Models 328-17 and 328-30Sekisui Diagnostics P.E.I. Inc.CJEClass II
K003069Anti-Cardiolipin, Multiple Autoantibodies Immunological Test SystemQuest Intl., Inc.MIDClass II
K002852N/t Protein Control SlSiemens Healthcare Diagnostics Inc.JJYClass I
K002342Branan Medical Corporation Monitect Bzo Drug Screen TestBranan Medical Corp.JXMClass II
K002268Branan Medical Corporation Monitect Morphine 2000 Drug Screen TestBranan Medical Corp.DJGClass II
K002265Branan Medical Corporation Monitect Methamphetamine Drug Screen TestBranan Medical Corp.DJCClass II
K002264Branan Medical Corporation Monitect Cocaine Drug Screen TestBranan Medical Corp.DIOClass II
K002263Branan Medical Corporartion Monitect Thc Drug Screen TestBranan Medical Corp.LDJClass II
K001521SoftsensIntegrated Biosensing TechnologiesGXYClass II
K003428Iss Offset HeadsZimmer GmbHHSDClass II
K003413Alumina V40 HeadHowmedica Osteonics CorpLZOClass II
K003384Versalink Titanium Rod-to-Rod CouplersOsteotech IncMNHClass II
K003046Image Vascular LaserSciton, Inc.GEXClass II
K003028Cytoplast Suture; Cs-0318, Cs-0416, Cs-0418, Cs-0513, Cs-0513Pc, Cs-0516HcOsteogenics Biomedical, Inc.NBYClass II
K002931Metrx SystemMedtronic Sofamor DanekHRXClass II
K002886Implantech Composite Facial Implants (Malar, Chin, and Nasal)Implantech Associates IncLZKClass II
K002765Licox Cmp Monitor-Ac3.1, Licox Imc Oxygen Catheters-Cc1,cc1.sb Luicox Imc Introducer Kits-Im,im2,im3,ii1 Licoximc TempeIntegra NeuroSciencesGWMClass II
K002764Hydrocision Arthrojet System with Cautery and BurrHydrocision, Inc.HRXClass II
K002757Oncology Salvage SystemZimmer GmbHJDIClass II
K002184Cod Compression Osteotomy DeviceWalter Abendschein, M.D.HRSClass II
K002098Salumedica Nerve CuffSalumedica, LLCJXIClass II
K001692Neuro Scan Medical Ststems, Model Medicor 8Neurosoft LtdJXEClass II
K001564Scan Lt40 (40 Channels)Neuro Scan LabsOLTClass II
K000651Detach 18 and Detach 11, Neurological Embolization Coil SystemCook Inc.HCGClass II
K003525Voluson 730 Diagnostic Ultrasound SystemMedison America, Inc.IYNClass II
K003370Jamshidi Marrow Acquisition CradleMedtronic, Inc.KNWClass II
K003365S.m.a.r.t Nitinol Stent Endosopic Billary System (Various)Cordis US Corp.FGEClass II
K003353Medline Aloe Touch Sterile Nitrile Examination Gloves with Aloe VeraMEDLINE INDUSTRIES, LP - NorthfieldLZAClass I
K003336Modification to S.m.a.r.t Nitinol Stent Transhepatic Biliary SystemCordis US Corp.FGEClass II
K003321Disposable Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green ColorShanghai Antares Industries, Inc.LYZClass I
K003309Dermagrip Powder Free Green Polymer Coated Examination Gloves Contains 50 Micrograms or Less of Total Water ExtractableWrp Specialty Products Sdn. Bhd.LYYClass I
K003307Dermagrip Powder Free Pink Polymer Coated Latex Examination Glove, Non-Sterile Contains 50 Micrograms or Less of Total WWrp Specialty Products Sdn. Bhd.LYYClass I
K003306C. Difficile Tox A/b IITechlab, Inc.LLHClass I
K003304Im-6 MicroinjectorNarishige Co., Ltd.MQJClass II
K003303Im-5B MicroinjectorNarishige Co., Ltd.MQJClass II
K003302Im-5A InjectorNarishige Co., Ltd.MQJClass II
K003300Mo-202D Three-Axis Hanging Joystick Oil Hydraulic MicromanipatorNarishige Co., Ltd.MQJClass II
K003197Vinyl, Powder-Free, Patient Examination Gloves, YellowKaohsiung Brothers Products Corp.LYZClass I
K003142MicromanipulatorResearch Instruments LtdMQJClass II
K003063Gimbel Puncture Resistant Latex Surgical Glove with Puncture Resistance Fingertip ProtectionGimbel Glove Co.KGOClass I