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

Filters: Cleared only ×
175,820 results
29857–29880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2017
Arrowhead Mini-Rail Fixator
K162032 · KTT
Arrowhead De, LLC
Orthopedic · 214d
Cleared Feb 21, 2017
AlignMATE™ Lapidus Arthrodesis System
K162391 · HRS
Arthrosurface, Inc.
Orthopedic · 179d
Cleared Feb 21, 2017
VariAx Distal Radius Plating System, VariAx 2 System
K162841 · HRS
Stryker GmbH
Orthopedic · 133d
Cleared Feb 21, 2017
Omron HEM-6400T-Z Wrist Blood Pressure Monitor
K163045 · DXN
Omron Healthcare, Inc.
Cardiovascular · 113d
Cleared Feb 21, 2017
ClearLumen II Peripheral Thrombectomy System
K163051 · QEZ
Walk Vascular, LLC
Cardiovascular · 112d
Cleared Feb 21, 2017
VibraPEP
K163091 · BWF
Medica Holdings, LLC
Anesthesiology · 109d
Cleared Feb 21, 2017
TRU Legionella
K163273 · MJH
Meridian Bioscience, Inc.
Microbiology · 92d
Cleared Feb 21, 2017
ELECTROmatic
K163317 · EBW
Kaltenbach & Voigt Gmgh
Dental · 90d
Cleared Feb 21, 2017
SpeedLyser Infusion Catheter Kit
K170258 · QEY
AngioDynamics, Inc.
Cardiovascular · 25d
Cleared Feb 18, 2017
VIA 17 Microcatheter
K162565 · DQY
Sequent Medical, Inc.
Cardiovascular · 157d
Cleared Feb 18, 2017
AXIOS Stent and Electrocautery Enhanced Delivery System
K163272 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 89d
Cleared Feb 17, 2017
Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal...
K160200 · BWC
Cook Incorporated
Anesthesiology · 386d
Cleared CT Feb 17, 2017
GenNarino
K160799 · LTF
Saliwell , Ltd.
Dental · 331d
Cleared Feb 17, 2017
Care Cycle Connect Application
K161411 · MOD
Respironics, Inc.
Anesthesiology · 273d
Cleared Feb 17, 2017
ReDe Mask
K161953 · PRK
Tereopneuma
Anesthesiology · 214d
Cleared Feb 17, 2017
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
K162281 · LCP
Sebia
Chemistry · 186d
Cleared Feb 17, 2017
Z-Span Plate System
K162824 · KWQ
Zavation, LLC
Orthopedic · 133d
Cleared Feb 17, 2017
Sentry IVC filter
K162875 · DTK
Novate Medical , Ltd.
Cardiovascular · 126d
Cleared Feb 17, 2017
Intra medullary endo-transilluminating device (iMET device)
K163037 · HRX
WeMED Bio-Tech, Inc.
Orthopedic · 109d
Cleared CT Feb 17, 2017
SeptiCyte LAB
K163260 · PRE
Immunexpress, Inc.
Microbiology · 88d
Cleared Feb 17, 2017
ExpressBraid Graft Manipulation
K163651 · GAT
Biomet Manufacturing Corp
General & Plastic Surgery · 56d
Cleared Feb 16, 2017
AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose...
K153561 · NBW
Andon Health Co, Ltd.
Chemistry · 430d
Cleared Feb 16, 2017
VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)
K161437 · LON
bioMerieux, Inc.
Microbiology · 268d
Cleared Feb 16, 2017
TAP Blood Collection Device
K161521 · PRJ
Seventh Sense Biosystems, Inc.
Chemistry · 259d