FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
29833–29856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 2016
Stryker Universal Mesh
K161821 · GWO
Stryker
Neurology · 160d
Cleared Dec 08, 2016
Reprocessed Response Diagnostic Electrophysiology Catheters
K161827 · NLH
Innovative Health, LLC
Cardiovascular · 156d
Cleared Dec 08, 2016
Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
K162005 · HQD
Acuity Polymers, Inc.
Ophthalmic · 141d
Cleared Dec 08, 2016
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System
K162194 · KWQ
Medicrea International SA
Orthopedic · 125d
Cleared Dec 08, 2016
ProNova SC360 Proton Therapy System
K162246 · LHN
Pronova Solutions, LLC
Radiology · 120d
Cleared Dec 08, 2016
CAAS MR 4D Flow
K162376 · LLZ
Pie Medical Imaging BV
Radiology · 106d
Cleared Dec 08, 2016
Proture Double Electric Breast Pump
K162747 · HGX
Guangdong Horigen Mother & Baby...
Obstetrics & Gynecology · 69d
Cleared Dec 08, 2016
VIPER PRIME™ additions to the VIPER® System
K162912 · NKB
Medos International SARL
Orthopedic · 52d
Cleared Dec 08, 2016
DC-UIBC-CAL
K163078 · JIT
Sekisui Diagnostics P.E.I., Inc.
Chemistry · 35d
Cleared Dec 07, 2016
Rheumatoid Factor (RF) Kit for use on SPAPLUS
K160070 · DHR
The Binding Site Group , Ltd.
Immunology · 329d
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