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
22921–22944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 2019
Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0...
K182475 · GDW
Covidien
General & Plastic Surgery · 185d
Cleared Mar 14, 2019
Omron Model BP7900 Blood Pressure Monitor + EKG
K182579 · DXN
Omron Healthcare, Inc.
Cardiovascular · 176d
Cleared Mar 14, 2019
BD Plastipak Syringe
K182589 · FMF
Becton, Dickinson and Company
General Hospital · 175d
Cleared Mar 14, 2019
PathVisionXL
K183142 · MWP
Faxitron Bioptics, LLC
Radiology · 121d
Cleared Mar 14, 2019
dpl Faceware
K183247 · OHS
Led Technologies, Inc.
General & Plastic Surgery · 113d
Cleared Mar 14, 2019
Tetric PowerFill
K183380 · EBF
Ivoclar Vivadent, AG
Dental · 98d
Cleared Mar 14, 2019
Vstrip H. pylori Antigen Rapid Test
K183573 · LYR
Panion & BF Biotech, Inc.
Microbiology · 83d
Cleared Mar 14, 2019
Aquas Probes
K190168 · GEI
Genicon, Inc.
General & Plastic Surgery · 42d
Cleared Mar 14, 2019
PROSTIM Injectable Inductive Graft
K190283 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 31d
Cleared Mar 14, 2019
L300 Go System
K190285 · GZI
Bioness, Inc.
Neurology · 31d
Cleared Mar 14, 2019
VASOBand Vascular Compression Device
K190318 · DXC
Vasoinnovations, Inc.
Cardiovascular · 29d
Cleared Mar 14, 2019
VITROS XT Chemistry Products UREA-CREA Slides
K190326 · CDN
Ortho-Clinical Diagnostics, Inc.
Chemistry · 29d
Cleared Mar 13, 2019
FasTouch Absorbable Fixation System
K181668 · GDW
Via Surgical , Ltd.
General & Plastic Surgery · 261d
Cleared Mar 13, 2019
Alteon Acetabular Cup System
K182502 · LPH
Exactech, Inc.
Orthopedic · 182d
Cleared Mar 13, 2019
Venture 0.014 Catheter
K182570 · DQY
Vascular Solutions, LLC
Cardiovascular · 176d
Cleared Mar 13, 2019
MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior...
K182920 · MAX
MiRus, LLC
Orthopedic · 145d
Cleared Mar 13, 2019
Wright Jones Fracture System
K183026 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 132d
Cleared Mar 13, 2019
DePuy Synthes Maxillofacial Portfolio - MR Conditional
K183113 · MQN
Synthes USA Products, LLC
Dental · 124d
Cleared Mar 13, 2019
BeneVision Central Monitoring System
K183238 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 113d
Cleared Mar 13, 2019
Modular Spinal Fixation System
K183430 · NKB
Life Spine, Inc.
Orthopedic · 92d
Cleared Mar 13, 2019
AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access...
K183463 · DQY
Stryker
Neurology · 89d
Cleared Mar 13, 2019
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
K183464 · NRY
Stryker
Neurology · 89d
Cleared Mar 13, 2019
DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR...
K183472 · FTM
Synthes USA Products, LLC
General & Plastic Surgery · 89d
Cleared Mar 13, 2019
JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD...
K183492 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 86d