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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 2178 of 3531
510(k) clearances, page 2178 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K930867Auto Suture Disposable Uterine ManipulatorUnited States Surgical, A Division of Tyco HealthcLKFClass II
K922872Interpore Cylindrical Hex Hydroxyapatite Coated Implant, 3.3 Mm Diam.Interpore Intl.DZEClass II
K943311Eclipse 3200CardiogenesGEXClass II
K943089Argesol 830WArgen Precious Metals, Inc.EJTClass II
K943088Argesol RArgen Precious Metals, Inc.EJTClass II
K943087Argesol 750WArgen Precious Metals, Inc.EJTClass II
K943070Reusable ProbesSurgin Surgical Instrumentation, Inc.GCJClass II
K943037Argedent 41Argen Precious Metals, Inc.EJTClass II
K943032Aurium Y+Argen Precious Metals, Inc.EJTClass II
K942981Argesol #585Argen Precious Metals, Inc.EJTClass II
K942980Argesol #615Argen Precious Metals, Inc.EJTClass II
K942979Argesol-Argicraft-1Argen Precious Metals, Inc.EJTClass II
K942978Argesol #650Argen Precious Metals, Inc.EJTClass II
K942943Argesol-NovasolArgen Precious Metals, Inc.EJTClass II
K942929Argesol LoArgen Precious Metals, Inc.EJTClass II
K942668O-Tray Impression TraysDentauraum, Inc.EHYClass I
K942665Orthocent: Liquid and PowderDentauraum, Inc.EMAClass II
K941731Empty, Solution Transfer Container with Detatchable Leg SetIncutech, Inc.KPEClass II
K941554Sustain Hex Ha-Coated Cylinder Endosseous Implant SystemLifecore Biomedical LLCDZEClass II
K940718Innervision Inc. Laparoscopic Hand InstrumentsInnervision, Inc.HETClass II
K936314Odyssey Tan 2000Fitness to Go, Inc.LEJClass II
K935696Etex Ha Hip Replacement SystemEtex Corp.MEHClass II
K934729Ufc Hip Stem Components: Hydroxylapatite CoatedImplantology Corp.MEHClass II
K934657Brainlab Linac HardwareBrainlab Med. Computersysteme GmbHIYEClass II
K932759Tempoary Polycarbonate CrownsSouth American Dental Exporting Corp.ELZClass I
K932425Foundation Modular Tibial BaseplateEncore Orthopedics, Inc.JWHClass II
K932246Foundation Metal-Backed PatellaEncore Orthopedics, Inc.JWHClass II
K931782Mitek Giii AnchorMitek Surgical Products, Inc.JDRClass II
K930835Vivoperl-Pe, Vivaperl-Pe Orthotyp/orthotyp aIvoclar North America, Inc.ELLClass II
K923335Ultrasound Transucer, Model Us915 -- ModificationAdvanced Medical Systems, Inc.HGLClass II
K942928Argesol 500Argen Precious Metals, Inc.EJTClass II
K942859Argesol-YpfArgen Precious Metals, Inc.EJTClass II
K942747Malcolm-Lynn(tm) Eot Suction Reg Valve(tm) (Srv) )Engineered Orthopedic Technologies, Inc.KDPClass II
K942677Geenen/zebra GuidelinesBoston Scientific CorporationFDEClass II
K942615SyringeBD Becton Dickinson Vacutainer Systems PreanalyticFMFClass II
K940948Angled Dissectors Models 8383.581/582/571Richard Wolf Medical Instruments Corp.GCJClass II
K940335American Catheter Poly-SnareIntl. Medical, Inc.FDIClass II
K936249Medicon Instruments Unipolar Coagulation ElectrodesMedicon Instruments, Inc.GEIClass II
K936246Medicon Instruments Bipolar Forcepts and ElectrodesMedicon Instruments, Inc.GEIClass II
K935243Aesculap Flexible Trocar Instrument SetAesculap IncGCJClass II
K934159Ioi Cocr Unipolar ProsthesisIntermedics OrthopedicsKWYClass II
K933948Acufex Endobutton SystemAcufex Microsurgical, Inc.MAIClass II
K943144Auris CicGeneral Hearing Instruments, Inc.ESDClass I
K942971Auto Suture Spinal DissectorUnited States Surgical, A Division of Tyco HealthcHAOClass I
K942970Auto Suture Spinal ElevatorUnited States Surgical, A Division of Tyco HealthcHAOClass I
K942969Auto Suture Spinal Nerve HookUnited States Surgical, A Division of Tyco HealthcHAOClass I
K942968Auto Suture Spinal OsteotomeUnited States Surgical, A Division of Tyco HealthcHAOClass I
K942967Auto Suture Spinal CuretteUnited States Surgical, A Division of Tyco HealthcHAOClass I
K942925Conmed Andover Med ECG ElectrodesConmed Andover Medical, Inc.DRXClass II
K942831Hae 2Hearing Aid ExpressESDClass I