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 1946 of 3531
510(k) clearances, page 1946 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K963049Steri-Aid KitSteri-Aid, Inc.FQZClass I
K962792Linac Scalpel Treatment Planning SystemSurgical Navigation Technologies, Inc.IYEClass II
K962593Electrosurgical Probes & DevicesXimed/Prosure/InjectxGEIClass II
K963986Stp System Pva with ZincSage Products LLCLIOClass I
K963915Telex in-the-Ear Custom Hearing Aid with Threshold CompressionTelex Communications, Inc.ESDClass I
K963909Hemocue GlucolinDirect SolutionsJJXClass I
K963687Aia-Pack Ft3 AssayTosoh Medics, Inc.CDPClass II
K963617Shimadzu X-Ray Diagnostic Table Ysf-120Shimadzu Medical SystemsJAAClass II
K963579Pace-1A Cardiac StimulatorRadionics, Inc.JOQClass II
K963497Gammacell 3000 Elan, Version 1.0 and Gammacell 1000 Elite, Version 1.0Nordion International, Inc.MOTUnclassified
K963387Deluxe Limb Restraint with Double D-Ring and Strap Deluxe Limb Restraint with StrapMorrison Medical ProductsFMQClass I
K963374Torso/waist RestraintMorrison Medical ProductsFMQClass I
K963370Cinch Strap with BuckleMorrison Medical ProductsFMQClass I
K963192Synthes Sterile 3.5 Mm and 4.0 Mm Cannulated ScrewsSynthes (USA) Products LLCHWCClass II
K963172Synthes Sterile 4.5 Mm Cannulated ScrewsSynthes (USA) Products LLCHWCClass II
K963124Pc Laser with Smart Plug (Pc Edo & Dental 200)Fisma, Inc.GEXClass II
K963112Mmg Multi Lumon Extension SetMmg Healthcare, Inc.FPAClass II
K963098Pleur-Evac Shara Plus Model S-2150/Continuous Reinfusion Autotransfusion System(s-100)Deknatel, Inc.CACClass II
K962364Codonics Medical Printer (Np-1600M,np1600md)Codonics, Inc.LMCClass II
K962068Lightstic Model 180Rare Earth Medical, Inc.GEXClass II
K961834Philips Easyguide NeuroPhilips North America LLCHAWClass II
K961582External Pacemaker Analyzer, Model Pmt 100North American Technical Services Corp.DTCClass II
K954679Theraplan PlusTheratronics, Inc.IYEClass II
K964263Expert-Kl and Hand Acquisition and Analysis SoftwareLunar Corp.KGIClass II
K964113Ivalon Nasal Packing W/drawstring (8.0Cm & 4.5Cm), Ivalon Nasal Packing W/airway Tube & Drawstring, Ivalon Contour NasalM-Pact Worldwide Management Corp.EMXClass I
K964026Stp System - SafSage Products LLCLIOClass I
K964002Naturale Hcg Pregnancy TesMizuho USA, Inc.LCXClass II
K963893Fibre Interspaced X-Ray GridSmit RontgenIXJClass I
K963628Imageshare Computed Radiography Acquisition Station And/or SoftwareDejarnette Research SystemsLMDClass I
K963594Imageshare Secondary Capture Acquisition Station And/or Software (1000 Film Digitizer Acquisition Station)Dejarnette Research SystemsLMDClass I
K963592Imageshare Protocol Converting Gateway And/or Software [Os/2 Warp] 1Ooo,[sun/solaris] 2000Dejarnette Research SystemsLMDClass I
K963525Diastat Anti-Glomerular Basement Membrane KitShield Diagnostics, Ltd.DBLClass II
K963513Cardiac Status Troponin IPrinceton BioMeditech Corp.MMIClass II
K963426Karl Storz Contact Micro-LaryngoscopesKarl Storz Endoscopy-America, Inc.EOBClass II
K963372Heelbo Er Wrist RestraintHeelbo, Inc.FMQClass I
K963371Best Strap RestraintMorrison Medical ProductsFMQClass I
K963247Victor Model Ocpr Oxygen Conserving Pressure RegulatorThermadyne Holings Corp.NFBClass II
K963179Magnetic Resonance Diagnostic SystemGE HealthcareLNHClass II
K963171Cinch Qr Sgw ExtensionCordis US Corp.DQXClass II
K962366Heartport Cable Bulldog ClampHeartport, Inc.DXCClass II
K962180Cath SealUniversal Medical Instrument Corp.DYBClass II
K961593Intrastar Pre-Wired Faceplate for in-the-Ear Hearing AidsSegi Hearing Aid Co.LRBClass I
K961484Cass System (Modification)Medical Instrumentation & Diagnostics Corp.(Midco)IYEClass II
K960855Prestige Blood Glucose Monitoring System,meter,test Strips & Prestige High and Low Glucose ControlHome Diagnostics, Inc.CGAClass II
K955110Navarre Percutaneous Biliary DrainageNavarre Biomedical, Ltd.FGEClass II
K964065N/t Protein Control SlBehring Diagnostics, Inc.JJYClass I
K964052Hemocue HemotrolDirect SolutionsGGMClass II
K963912Tyco Baby Sesame Street Soft TeetherRegu-Tech Assoc., Inc.KKOClass II
K963897Steri-Oss Sinus Augmentation KitSteri-Oss, Inc.EMMClass I
K963867Neo-Care Catheterization TrayKlein-Baker Medical, Inc.FOZClass II