Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
40801–40824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 2013
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL...
K130585 · MUH
VATECH Co., Ltd.
Radiology · 132d
Cleared Jul 15, 2013
LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE
K130657 · NBW
All Medicus Co., Ltd.
Chemistry · 125d
Cleared Jul 15, 2013
NEOTIS
K130953 · MQV
Sbm Sciences For Bio Materials
Orthopedic · 101d
Cleared Jul 15, 2013
EXTAVIPRO STERICAN 30G
K131040 · FMI
B.Braun Melsungen AG
General Hospital · 91d
Cleared Jul 15, 2013
ANA SCREEN ELISA (IGG)
K131185 · LJM
Euroimmun US
Immunology · 80d
Cleared Jul 15, 2013
EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION...
K131382 · MWI
Invivo Corporation
Cardiovascular · 62d
Cleared Jul 15, 2013
TRUSCOPE SERIES PATIENT MONITOR
K131763 · MHX
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 28d
Cleared Jul 12, 2013
SURGITRON 4.0 DUAL RF S5-IEC
K123366 · GEI
Ellman International, Inc.
General & Plastic Surgery · 254d
Cleared Jul 12, 2013
INGENUITY DIGITAL PET/CT
K123599 · KPS
Philips Healthcare (Cleveland)
Radiology · 233d
Cleared Jul 12, 2013
IPULSE HAIR REMOVAL SYSTEM
K130315 · OHT
Cyden Limited
General & Plastic Surgery · 154d
Cleared Jul 12, 2013
SOLEA
K130420 · GEX
Convergent Dental, Inc.
General & Plastic Surgery · 143d
Cleared Jul 12, 2013
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
K130806 · PDQ
Neurovision Medical Products, Inc.
Neurology · 109d
Cleared Jul 12, 2013
YAMAHACHI DENTURE BASE RESINS
K131036 · EBI
Yamahachi Dental Manufacturing Co.
Dental · 88d
Cleared Jul 12, 2013
SHARPSTANK REUSABLE SHARPS CONTAINER
K131087 · MMK
Rehrig Pacific Company
General Hospital · 85d
Cleared Jul 12, 2013
PADSCAN HD SERIES BLADDER SCANNER
K131227 · IYO
Carenoso Technology Co., Ltd.
Radiology · 73d
Cleared Jul 12, 2013
FACET FIXX
K131417 · MRW
Nexxt Spine, LLC
Orthopedic · 57d
Cleared Jul 12, 2013
MIPLATFORM MEDICAL IMAGING SUITE
K131424 · LLZ
Hinacom Software and Technology, Ltd.
Radiology · 56d
Cleared Jul 12, 2013
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K131514 · IYN
Ge Vingmed Ultrasound AS
Radiology · 45d
Cleared Jul 12, 2013
LANX FUSION SYSTEM
K131547 · OVD
Lanx, Inc.
Orthopedic · 44d
Cleared Jul 12, 2013
ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
K131637 · GDW
Rotation Medical, Inc.
General & Plastic Surgery · 38d
Cleared Jul 12, 2013
REMEL XPECT FLU A&B
K131804 · GNX
Remel, Inc.
Microbiology · 23d
Cleared Jul 11, 2013
MESOTHELIUM DENTAL MEMBRANE
K121310 · NPL
Kensey Nash Corporation
Dental · 436d
Cleared Jul 11, 2013
BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B
K123075 · NGX
Well-Life Healthcare Limited
Physical Medicine · 283d
Cleared Jul 11, 2013
THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
K123343 · MLM
Microgenics Corp.
Toxicology · 253d