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
23521–23544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 13, 2019
Anchor Bag-Alone Tissue Retrieval System by ConMed
K183600 · GCJ
Conmed Corporation
General & Plastic Surgery · 77d
Cleared Mar 13, 2019
GammaTile
K190296 · KXK
Gt Medical Technologies
Radiology · 30d
Cleared Mar 13, 2019
BIOK7600W Wireless Flat Panel Detector
K190300 · MQB
Biokinemetrics, Inc.
Radiology · 29d
Cleared Mar 13, 2019
BIOK7600 Flat Panel Detector
K190311 · MQB
Biokinemetrics, Inc.
Radiology · 29d
Cleared Mar 13, 2019
Enhanced Feature Software Pack CXDI Series
K190368 · MQB
Canon, Inc.
Radiology · 26d
Cleared Mar 12, 2019
Safety insulin needle for single use
K181447 · FMI
Berpu Medical Technology Co., Ltd.
General Hospital · 284d
Cleared Mar 12, 2019
ActivOrtho Nitinol Compression Screw System
K181610 · HWC
Activortho, Inc.
Orthopedic · 266d
Cleared Mar 12, 2019
ISS-JAZZ Screw System and JAZZ CAP SP
K182771 · NKB
Implanet, S.A.
Orthopedic · 165d
Cleared Mar 12, 2019
Endotoxin Activity Assay (EAA)
K183176 · NGS
Spectral Medical, Inc.
Microbiology · 116d
Cleared Mar 12, 2019
Caiman 5 Maryland
K183180 · GEI
Aesculap, Inc.
General & Plastic Surgery · 113d