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
24337–24360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 2018
V3 Segmental Plating System
K182418 · KWQ
Atlas Spine, Inc.
Orthopedic · 85d
Cleared Nov 29, 2018
Device Electrosurgical Generator ESG-150
K182587 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 70d
Cleared Nov 29, 2018
Espire Elbow Pro, Espire Elbow Hybrid
K182757 · GXY
College Park Industries, Inc.
Neurology · 62d
Cleared Nov 29, 2018
Afinion HbA1c Dx on Afinion 2
K182988 · PDJ
Alere Technologies AS
Chemistry · 31d
Cleared Nov 28, 2018
Non-contact Infrared Thermometer
K180207 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 308d
Cleared Nov 28, 2018
NuVasive Reline Fenestrated Screws, High V+ Bone Cement
K180498 · PML
Nu Vasive, Incorporated
Orthopedic · 275d
Cleared Nov 28, 2018
SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System
K180665 · MQP
K2m, LLC
Orthopedic · 259d
Cleared Nov 28, 2018
Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite
K181604 · ELW
Hrs Co., Ltd.
Dental · 162d
Cleared Nov 28, 2018
SMS Femoral Stem
K181693 · LZO
Medacta International S.A.
Orthopedic · 154d
Cleared Nov 28, 2018
AEON Endoscopic Stapler
K182380 · GDW
Lexington Medical, Inc.
General & Plastic Surgery · 89d
Cleared Nov 28, 2018
BGM014 Blood Glucose Monitoring System
K182992 · NBW
Apex BioTechnology Corp.
Chemistry · 30d
Cleared Nov 28, 2018
Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks
K183010 · JWH
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Nov 27, 2018
AdVance XP Male Sling
K182169 · OTM
Boston Scientific Corporation
Gastroenterology & Urology · 109d
Cleared Nov 27, 2018
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
K182353 · LJM
Phadia AB
Immunology · 90d
Cleared Nov 27, 2018
gammaCore Sapphire
K182369 · PKR
Electrocore, Inc.
Neurology · 88d
Cleared Nov 27, 2018
ATEC ALIF and LLIF Spacer System
K182746 · MAX
Alphatec Spine, Inc.
Orthopedic · 60d
Cleared Nov 27, 2018
Biop Digital Colposcope
K182764 · HEX
Biop Medical , Ltd.
Obstetrics & Gynecology · 60d
Cleared Nov 27, 2018
Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator...
K182801 · GEI
Integra LifeSciences Corporation
General & Plastic Surgery · 56d
Cleared Nov 27, 2018
iFuse Implant System®
K182983 · OUR
SI-BONE, Inc.
Orthopedic · 29d
Cleared Nov 26, 2018
Low-frequency Multi-function physiotherapy instrument
K172837 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 433d
Cleared Nov 26, 2018
Orchestrate 3D
K181112 · PNN
Orchestrate 3D
Dental · 213d
Cleared Nov 26, 2018
ARiX RAD Radiographic System
K182134 · KPR
Compania Mexicana DE Radiologia Cgr,...
Radiology · 112d
Cleared Nov 26, 2018
EkoSonic Endovascular System
K182324 · QEY
Btg International, Inc.
Cardiovascular · 91d
Cleared Nov 26, 2018
TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
K182346 · MBH
Exactech, Inc.
Orthopedic · 90d