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 1803 of 3531
510(k) clearances, page 1803 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K981928Galileo Disposable EndoscopesGalileo Electro-Optics Corp.GCJClass II
K981919Bissinger Cables, Cat. No. 801000XxGuenter Bissinger Medizintechnik GmbHGEIClass II
K981684Stealthstation Treatment Guidance PlatformSurgical Navigation Technologies, Inc.HAWClass II
K981504Dbest Amphetamines Test KitAmeritek, Inc.DKZClass II
K981263ToxogenInstrumentation Laboratory Co.GMMClass II
K980868Gc IrrigatorGentle Colonics, Inc.KPLClass II
K980477Image Vue EEGSam Technology, Inc.OLXClass II
K974849X-Air-CiserHougen Mfg., Inc.BYIClass II
K974848Mini-CiserHougen Mfg., Inc.BWFClass II
K9748475.0Mm Parachute Corkscrew Suture Anchor Model Ar-22255, 3.5Mm Parachute Corkscrew Suture Anchor Model Ar-22235Arthrex GmbHMBIClass II
K974539Sullivan Vpap II St Ventilatory Support SystemResMed CorpMNTClass II
K982591Dade Tru-Liquid Cardiac ControlSiemens Healthcare Diagnostics Inc.JJXClass I
K982364Wireless Standard Probe, Dynamic Reference Frame (Drf)Radionics, Inc.HAWClass II
K982309Smoke Evacuation Attachment 130Xxx TbdConmedcorpGEIClass II
K982236Sigma Diagnostics Infinity Bun Reagent KitSigma Diagnostics, Inc.CDQClass II
K982051Kelocate SheetingAllied Biomedical Corp.MDAClass I
K981908Um-150AUmeco Union Medical EngineeringGEIClass II
K981852Silimed Tissue ExpanderSilimed, LLCLCJUnclassified
K981796Light Saber Core Tissue NeedleMinrad, Inc.KNWClass II
K981756Shelhigh No-React PneumopledgetsShelhigh, Inc.FTLClass II
K981704Aurex-3Adm Tronics Unltd, Inc.KLWClass II
K981642Stablemapr Steerable Intracardiac CathetersMedtronic CardiorhythmDRFClass II
K981640S2loOdyssey Optical Systems, LLCHLIClass II
K981628Bard Quantum Svr Model Number H-6440VrC.R. Bard IncDTNClass II
K980782Stat-Simple PyloriSaliva Diagnostic Systems, Inc.LYRClass I
K980148Neurosign 800, 8 Channel Motor Nerve MonitorMagstim Inc.ETNClass II
K980052RespaideEmergency Filtration Products, Inc.CBPClass II
K974479Silimed Vaginal StentSilimed, LLCKXPClass II
K971892Biomedical Horizons Inc. Compression Pump, Model 651Biomedical Horizons, Inc.JOWClass II
K961798CT 200 ElectrocardiographMacquarie Medical SystemsDPSClass II
K982129Antagon PorcelainEuropean Dental Imports, Inc.EIHClass II
K981907V.f.i.-Viscous Fluid Infusion Tubing SetPeregrine Surgical, LLC.MRHClass II
K981819Angiolaz Ves-1CamAngiolaz, Inc.FWFClass I
K981624Flo-ThruBio-Vascular, Inc.DXCClass II
K980761Synthes Spine Pediatric Rod SystemSynthes GmbHMNHClass II
K980553Narkomed 6000 Model Number Nm6000Draeger, Inc.BSZClass II
K980208Divan Anesthesia VentilatorDraeger, Inc.CBKClass II
K980197Ultracon/ultracon S Rigid Gas Permeable Contact Lens for Daily WearSpecialty Ultravision, Inc.HQDClass II
K974648Sulzer Carbomedics Low Profile Mitral RotatorSulzer Carbomedics, Inc.MOPClass I
K974453Nasal Interface Model 7910Healthdyne Technologies, Inc.BZDClass II
K982285Powderfree Green Latex Examination GlovesBesglove Medicare Sdn. Bhd.LYYClass I
K982284Powdered Green Latex Examination GlovesBesglove Medicare Sdn. Bhd.LYYClass I
K982257Vinyl Patient Examination Gloves-Pre-PowderedTaian Plastics Products (Jingxing) Co., Ltd.LYZClass I
K982015Vinyl Patient Examination Powder Free Gloves, Non-SterileTaian Plastics Products (Jingxing) Co., Ltd.LYZClass I
K981898Orthovu-1000MagnevuLNHClass II
K981776Alexander Manufacturing Co. Battery Part Number Mc146xAlexander Mfg. Co.FRNClass II
K981303Direct LdlAbbott MedicalMRRClass I
K981224Direct HdlAbbott MedicalLBSClass I
K981181Ena-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use)Actimed Laboratories, Inc.CHHClass I
K980106The Proma Perception, Response and Compass System and AccessoriesProma, Inc.EIAClass I