FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
26497–26520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 2018
Exactech Equinoxe Stemless Shoulder
K173388 · PKC
Exactech, Inc.
Orthopedic · 130d
Cleared Mar 09, 2018
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management...
K173426 · OMP
Kci USA, Inc.
General & Plastic Surgery · 127d
Cleared Mar 09, 2018
Amsco Evolution Medium Steam Sterilizer
K173481 · FLE
STERIS Corporation
General Hospital · 116d
Cleared Mar 09, 2018
L300 Go System
K173682 · GZI
Bioness, Inc.
Neurology · 98d
Cleared Mar 09, 2018
Grass TWin
K173690 · OLV
Natus Medical Incorporated Dba...
Neurology · 98d
Cleared Mar 09, 2018
Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical...
K173796 · FTL
Sofradim Production
General & Plastic Surgery · 85d
Cleared Mar 09, 2018
Catalyst CSR 3 Peg Glenoids
K173812 · KWT
Catalyst Orthoscience, Inc.
Orthopedic · 84d
Cleared Mar 09, 2018
CATS Tonometer Prism
K173904 · HKY
Cats Tonometer, LLC
Ophthalmic · 77d
Cleared Mar 09, 2018
Quantib Brain
K173939 · LLZ
Quantib B.V.
Radiology · 73d
Cleared Mar 09, 2018
VORTEK URETERAL DOUBLE LOOP STENT
K180057 · FAD
Coloplast Corp.
Gastroenterology & Urology · 60d
Cleared Mar 09, 2018
UltraCor Twirl Breast Tissue Marker
K180061 · NEU
Bard Peripheral Vascular, Inc.
General & Plastic Surgery · 60d
Cleared Mar 09, 2018
Klassic® Knee System
K180159 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 49d
Cleared Mar 09, 2018
BrightMatter Plan 1.6.0
K180394 · LLZ
Synaptive Medical, Inc.
Radiology · 24d
Cleared Mar 08, 2018
AW-100
K171150 · ELC
Micron Corporation
Dental · 323d
Cleared Mar 08, 2018
ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws,...
K171320 · HRS
Meril Healthcare Pvt. , Ltd.
Orthopedic · 308d
Cleared Mar 08, 2018
Navigated Instrument System
K172115 · OLO
Orthofix, Inc.
Orthopedic · 238d
Cleared Mar 08, 2018
Neuro Assessment System NAS-1000
K172892 · QBE
Headsense Medical, Inc.
Neurology · 167d
Cleared Mar 08, 2018
ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device...
K173075 · MQK
Dxnow, Inc.
Obstetrics & Gynecology · 160d
Cleared Mar 08, 2018
CD HORIZON™ Spinal System
K173249 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 149d
Cleared Mar 08, 2018
AnastoClip GC Closure System
K173323 · FZP
LeMaitre Vascular, Inc.
General & Plastic Surgery · 139d
Cleared Mar 08, 2018
Carriere SLX 3D Clear
K173440 · NJM
Ortho Organizers, Inc.
Dental · 122d
Cleared Mar 08, 2018
NMF004A
K173500 · EBF
GC America, Inc.
Dental · 115d
Cleared Mar 08, 2018
iQMR
K173605 · LLZ
Medic Vision - Imaging Solutions, Ltd.
Radiology · 107d
Cleared Mar 08, 2018
syngo.CT Clinical Extensions
K173625 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 104d