510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
45,969 of the 176,366 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
20262,569
176,366 records, page 3312 of 3528
510(k) clearances, page 3312 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K810202Cordis Multifilar Pervenous Ventric. LdCordis US Corp.DTBClass III
K810196System 84 Computerized Lung Vol. SpiromCardio Pulmonary InstrumentsBZCClass II
K810181Dermotophyte Test MediumTroy Biologicals, Inc.JSJClass I
K810149Tongue CleanerAgp, Inc.LCNClass I
K810147Esophageal Stethoscope Temperature ProbeAbbott MedicalBZTClass II
K810099Airways-OropharyngealAmerican Hospital SupplyCAEClass I
K810047Autophor 128Gelman Sciences, Inc.JBDClass II
K810041Cordis Temporaty Curved Atrial LeadCordis US Corp.LDFClass II
K810020Panje Voice ProsthesisXomed, Inc.EWLClass II
K810005Safeed Extension TubesTerumo Medical Corp.FPKClass II
K803306Aloft Sterilization WrapAmerican Hospital SupplyFRGClass II
K803226Evoked Response StimulatorsBio-Logic Systems Corp.GWKClass II
K803145Conphar Eye ProtectorConphar, Inc.HMPClass I
K802971Landers Contact LensCooper Medical Devices Corp.HJIClass I
K802927Sebestyen Irrigating Contact LensCooper Medical Devices Corp.HJIClass I
K802864Siemens-Elema Pulse Generator 678Siemens Elema ABDXYClass III
K802175Implantable Ventricular-Inhibited CardiTelectronics, Inc.
K802140Leksell Stereotactic SystemDowns Surgical, Ltd.IWYClass I
K801810Pacemaker Patient Mgmt. SystemSiemens Elema ABDQKClass II
K810222Limb OrhtosisMedical Design & Manufacturing Corp.ITQClass I
K810220Powered Patient SystemTri W-G, Inc.IKZClass II
K810201Toxicology ControlUtak Laboratories IncLASClass I
K810186Micromedic Systems' AutopakMicromedic SystemsCGNClass II
K810184Laparotomy SpongeMedical Action Industries, Inc. 306GDYClass I
K810162Fogarty Softjaw 6Mm Spring Clip, #614-06American Edwards LaboratoriesDXCClass II
K810124Swan-Ganz Vip Thermodilution CatheterAmerican Edwards LaboratoriesDYGClass II
K810120Reinforced Hip CupZimmer GmbHJDIClass II
K810116Isorobic Skinfold CaliperFitness Motivation Institute of AmericaKTZClass I
K810112Swr Disposable Prep RazorG.D. Searle and Co.KDCClass I
K810111Cellona Plaster VarnishSecol Co.ITGClass I
K810075AutoclixBiodynamics Corp.FMKClass II
K803312Micromedic Automatic Computing CenterMicomedic SystemsJQPClass I
K803311Ll100 Cryosurgical SystemCooperSurgical, Inc.GEHClass II
K803235Geo-Tibial Retainer RotationalZimmer GmbHHSXClass II
K803195System 1 Instrument StandSurgical Mechanical Research, Inc.HMFClass I
K803194Fisher-Pickering Intraocular Eye MagnetStorz Instrument Co.HNRClass I
K803159Automated PerimetersCoburn Optical Ind., Inc.HPTClass I
K803037William Harvey Vented Mediastinal DrainC.R. Bard IncDWMClass II
K802942Hitemp. Tm 2 Looptip CauteryMedical Products Development, Inc.GEIClass II
K802904Microscope Model Om-UJEDMED Instrument CompanyEPTClass I
K802903Microscope Model Om-PJEDMED Instrument CompanyEPTClass I
K802687Speakeasy Commun. System-Comm. ProthesisIntelligent Software Systems, Inc.ILQClass II
K802199Stat-Crit Hematocrit Measuring InstruUnited States Surgical, A Division of Tyco HealthcGKFClass II
K810173Temperature Function BlockHoneywell, Inc.FLLClass II
K810144Alk-Phos Biopak GelBioware ProductsCINClass II
K810136Uric Acid Reagent SystemAmerican Monitor Corp.KNKClass I
K810129Centrifichem System 500Union Carbide Corp.JJEClass I
K810106Shiley Single Cannula Tracheostomy TubeShiley, Inc.BTOClass II
K810105Bca 1000Biodynamics Corp.JJQClass I
K810094Denture Rubber Base MaterialBosworth Co.EBIClass II