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

Filters: Cleared only ×
175,820 results
52849–52872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 2009
REST ASSURED GENERATION II DENTAL PROTECTOR
K091792 · OBR
Ranir Corporation
Dental · 21d
Cleared Jul 08, 2009
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM
K091882 · KRD
MicroVention, Inc.
Cardiovascular · 14d
Cleared Jul 07, 2009
STREAMER POLYMER GUIDEWIRE
K083094 · DQX
Brivant, Ltd.
Cardiovascular · 263d
Cleared Jul 07, 2009
PACS PLUS 5TH EDITION
K083658 · LLZ
Medical Standard Co., Ltd.
Radiology · 209d
Cleared Jul 07, 2009
POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR
K090194 · LZA
Shen Wei (Usa), Inc.
General Hospital · 161d
Cleared Jul 07, 2009
TANITA BODY COMPOSITION ANALYZER, MODEL SC-331
K090479 · MNW
Tanita Corporation of America
Gastroenterology & Urology · 133d
Cleared Jul 07, 2009
SMARTSCREENER-PLUS2
K090579 · GWJ
Intelligent Hearing Systems
Neurology · 126d
Cleared Jul 07, 2009
MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER
K090670 · FLE
Midmark Corp.
General Hospital · 116d
Cleared Jul 07, 2009
CORTEX DENTAL IMPLANT SYSTEM
K090709 · DZE
Cortex Dental Implants Industries , Ltd.
Dental · 111d
Cleared Jul 07, 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K090779 · MNI
Alphatec Spine, Inc.
Orthopedic · 106d
Cleared Jul 07, 2009
TIGRT MLC, TIGRT DMLC
K090802 · IYE
Linatech, LLC
Radiology · 105d
Cleared Jul 07, 2009
PACSMATE, MODEL MMD-4300C/MMD-4300CX
K091687 · LLZ
Iei Technology Corp.
Radiology · 27d
Cleared Jul 07, 2009
MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)
K091694 · HWC
Tag Medical Products
Orthopedic · 27d
Cleared Jul 07, 2009
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM
K091783 · FDF
Avantis Medical Systems, Inc.
Gastroenterology & Urology · 20d
Cleared Jul 06, 2009
POWER STANDING DANI
K090256 · IPL
Davismade, Inc.
Physical Medicine · 154d
Cleared Jul 06, 2009
BECE PRESS
K090434 · EIH
Bego Bremer Goldschlaegerei Wilh....
Dental · 137d
Cleared Jul 06, 2009
C.T.M. MOBILITY SCOOTER, HS-528
K090735 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 109d
Cleared Jul 06, 2009
MITAKA UNIARM
K090792 · GCJ
Mitaka Kohki Co., Ltd.
General & Plastic Surgery · 104d
Cleared Jul 06, 2009
ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS...
K090901 · NUA
Osmetech Molecular Diagnostics
Pathology · 96d
Cleared Jul 06, 2009
BANTAM
K091242 · INO
Altimate Medical, Inc.
Physical Medicine · 69d
Cleared Jul 06, 2009
C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION
K091418 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 54d
Cleared Jul 06, 2009
HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4
K091482 · IOR
Danyang Huayi Medical Supply &...
Physical Medicine · 48d
Cleared Jul 06, 2009
FREEDOM SCIENCES MOTION CONTROL MODULE VERSION 1.5
K091723 · ITI
Freedom Sciences, LLC
Physical Medicine · 25d
Cleared Jul 06, 2009
MEDICAL TREATMENT CHAIR, T400, T500,T600
K091727 · INO
Fresenius Medical Care South Asia...
Physical Medicine · 25d