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
30433–30456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 2016
OIC Cervical PEEK Spacer
K160222 · ODP
The Orthopaedic Implant Company
Orthopedic · 313d
Cleared Dec 07, 2016
s-Clean OneQ-SL Narrow Implant System
K161244 · DZE
Dentis Co., Ltd.
Dental · 218d
Cleared Dec 07, 2016
CT CoPilot
K161322 · LLZ
Zepmed, LLC
Radiology · 210d
Cleared Dec 07, 2016
SUTUREFIX Curved Suture Anchor
K163034 · MBI
Smith and Nephew, Inc.
Orthopedic · 37d
Cleared Dec 07, 2016
GC70
K163115 · KPR
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Dec 06, 2016
Hospira Sapphire Sets
K160492 · MRZ
Hospira, Inc.
General Hospital · 288d
Cleared Dec 06, 2016
Talymed Suspension
K160695 · FRO
Marine Polymer Technologies, Inc.
General & Plastic Surgery · 267d
Cleared Dec 06, 2016
CRW STEREOTACTIC SYSTEM
K160811 · HAW
Integra LifeSciences Corporation
Neurology · 257d
Cleared Dec 06, 2016
Endura guidewire
K161702 · DQX
Vascular Solutions, Inc.
Cardiovascular · 169d
Cleared Dec 06, 2016
Reprocessed Supreme Diagnostic Electrophysiology Catheters
K161769 · DRF
Innovative Health, LLC
Cardiovascular · 161d
Cleared Dec 06, 2016
OnSite-IV
K161800 · LHI
Pharmc, LLC
General Hospital · 159d
Cleared Dec 06, 2016
ShurFit CpTi-HA ACIF Interbody Fusion System
K161809 · ODP
Precision Spine, Inc.
Orthopedic · 158d
Cleared Dec 06, 2016
Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport...
K162304 · FPA
Quest Medical, Inc.
General Hospital · 111d
Cleared Dec 06, 2016
DiLumen Endolumenal Interventional Platform
K162428 · FDF
Lumendi, LLC
Gastroenterology & Urology · 98d
Cleared Dec 06, 2016
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
K162896 · DTZ
Medtronic, Inc.
Cardiovascular · 50d
Cleared Dec 06, 2016
Emprint Ablation System
K163105 · NEY
Covidien, LLC
General & Plastic Surgery · 29d
Cleared Dec 05, 2016
DENSEEMAMMO v1.0
K152009 · LLZ
Statlife
Radiology · 503d
Cleared Dec 05, 2016
Transfer & Angled Abutment
K153015 · NHA
Osstem Implant Co., Ltd.
Dental · 417d
Cleared Dec 05, 2016
4.0 and 6.5 Cancellous Bone Screw and Washer
K160946 · HWC
Smv Scientific
Orthopedic · 244d
Cleared Dec 05, 2016
APEX Manual Wheelchair
K161425 · IOR
Motion Composites
Physical Medicine · 196d
Cleared Dec 05, 2016
WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
K161453 · NUH
Well-Life Healthcare Limited
Neurology · 193d
Cleared Dec 05, 2016
Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1
K161728 · FLL
Microfile Intellectual Property GmbH
General Hospital · 166d
Cleared Dec 05, 2016
Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear...
K161757 · GDW
Victor Medical Instruments Co., Ltd.
General & Plastic Surgery · 161d
Cleared Dec 05, 2016
PREMIUM Implant Systems SHELTA Implant Systems
K162004 · NHA
Sweden & Martina S.P.A.
Dental · 138d