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 1685 of 3531
510(k) clearances, page 1685 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K994367Umbilical Cord ClampMedical Sales Co.HFWClass II
K994309Solo Ortho 2Sybron Dental Specialties, Inc.DYHClass II
K994280Ultracision Harmonic Scalpel Sharp Curved Blade/fast Blade, Model Hf105Ethicon Endo-Surgery IncLFLUnclassified
K994257Locator Implant AnchorZest Anchors LLCDZEClass II
K994119Synocta Angled AbutmentsStraumann USA, LLCDZEClass II
K993609Sologuard Locking Plus SyringeSafeguard Medical Products, Inc.MEGClass II
K992513Therme-Pneu Computer, Wisap #7070C, #7070Cf, #7070Cm, #7070CmfWisap Gesellschaft Fur Wissenschaftl. App. Bau mbHHETClass II
K992481CO2-Op-Pneu Computer, Wisap #7050C, #7050Cf, #7050CmfWisap Gesellschaft Fur Wissenschaftl. App. Bau mbHHETClass II
K000644Supergloves Sterile Powdered Latex Examination GlovesSupermax Glove Manufacturing Sdn BhdLYYClass I
K000583Fasttake Compact Blood Glucose Monitoring SystemSelfcare, Inc.CGAClass II
K000550Otw Megalink Sds Biliary Stent SystemAdvanced Cardiovascular Systems, Inc.FGEClass II
K000501Electrosurgical Generator, Model S1Somnus Medical Technologies, Inc.GEIClass II
K000417Convertors Equipment DrapesMedtronic, Inc.KKXClass II
K000359Ebt Ultrafast CT Scanner System; Ultrafast CT Scanner System; C-100, C-150. C-150Lxp or C-150Xp Scanner Systems; ElectroImatron, Inc.JAKClass II
K000312Varelisa Sm AntibodiesPharmacia & Upjohn Company LLCLKPClass II
K000287Brahms Diagnostica Lumitest Anti-TpoBrahms Diagnostica, LLCJZOClass II
K000286Brahms Diagnostica Lumitest Anti-TgBrahms Diagnostica, LLCJZOClass II
K000211Build-It FrJeneric/Pentron, Inc.EBFClass II
K000087Marhukar Triple Lumen Catheter, Model 12 FrThe Kendal Co.FOZClass II
K000085PortsettPortsett, Inc.FMIClass II
K000077Steris Amsco Millennium Steam SterilizerSTERIS CorporationFLEClass II
K000042Elecsys B-Crosslaps CalcheckRoche Diagnostics GmbHJJXClass I
K994387Reliefband Nst Device, Model Wb-2L, Wb-6L, Wb-RlWoodside Biomedical, Inc.GZJClass II
K994385Baby FaceSonora Medical SystemsIYOClass II
K994366Tmzf Press Fit Ha Stem and Tmzf Press Fit Plus Ha StemHowmedica Osteonics CorpMEHClass II
K994287Fonar 360 Degree Magnetic Resonance Imaging ScannerFonar Corp.LNHClass II
K994267Fresenius 2008KFresenius Medical CareKDIClass II
K993122Msp M/k BladeMedical Sterile Products, Inc.HNOClass I
K991881125-Implant Seeds, Model Stm1250Sourcetech Medical, LLCKXKClass II
K990504Memotherm Colorectal StentC.R. Bard IncMQRClass II
K000695Ge Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging SystemGE HealthcareIYOClass II
K000551Image X-70 Plus Dental X-Ray UnitMedical Device Consultants, Inc.EHDClass II
K994364Synthes Button PlateSynthes (USA) Products LLCMBIClass II
K994347Centaur Spinal SystemHowmedica Osteonics CorpKWQClass II
K994242Bodystat 1500Mdd Body Composition Monitoring UnitBodystat LtdMNWClass II
K994015Accublade (Acs Model), Mk8507, Accublade (Hansotome Model), Mk8508Surgin Surgical Instrumentation, Inc.HNOClass I
K993938The Hommed Sentry, Model 1 SentryHommed, LLCDXNClass II
K993656Datex-Ohmeda Tonometry Module M-TonoGE HealthcareCCKClass II
K993358Sightsure Operation Indicator, Model Ss301Medevices, Inc.KNTClass II
K990975In-Line Hemostasis ValveMerit Medical Systems, Inc.DYBClass II
K990897Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb NebulizerPuritan-Bennett Ireland, Ltd.CAFClass II
K000538Mallory/head Lateralized Press-Fit FemoralZimmer GmbHLPHClass II
K000536Synthes Anterior Cslp SystemSynthes GmbHKWQClass II
K000086Wilson-Cook Reusable Hot Biopsy ForcepsWilson-Cook Medical Inc.KGEClass II
K000066Synthes (USA) Locking Condylar Plate (Lcp) SystemSynthes (USA) Products LLCHRSClass II
K000053Acl 9000 SystemInstrumentation Laboratory Co.JPAClass II
K000045PositubeParaproducts, Inc.BTRClass II
K994436Surgi-Vision Esophageal Stylet CoilSurgi-Vision, Inc.MOSClass II
K994368American Dental Products Caries-Detector PlusAmerican Dental Products, Inc.LFCClass II
K994357Bitem Lock, Models Sw006, Sw012Thermoelastic Technologies, Inc.EJFClass I