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
34849–34872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 2015
Reliance Cervical IBF System
K142269 · ODP
Reliance Medical Systems, LLC
Orthopedic · 298d
Cleared Jun 09, 2015
ELEVATE Spinal System
K142559 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 271d
Cleared Jun 09, 2015
Powered Wheelchair
K142770 · ITI
Aat Alber Antriebstechnik GmbH
Physical Medicine · 257d
Cleared Jun 09, 2015
APTUS Wrist 2.5 System
K142906 · HRS
Medartis AG
Orthopedic · 246d
Cleared Jun 09, 2015
SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202...
K143520 · JOJ
Crosstex
General Hospital · 179d
Cleared Jun 09, 2015
AMT Enteral Transition Adapters
K150034 · PIO
Applied Medical Technology, Inc.
Gastroenterology & Urology · 151d
Cleared Jun 09, 2015
TETRIC EVOFLOW BULK FILL
K150393 · EBF
Ivoclar Vivadent, AG
Dental · 111d
Cleared Jun 09, 2015
Capillus 272 Office Pro
K150578 · OAP
Capillus, LLC
General & Plastic Surgery · 92d
Cleared Jun 09, 2015
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K150593 · LZA
Hartalega Sdn Bhd
General Hospital · 92d
Cleared Jun 09, 2015
Morrison Steerable Needle
K150625 · KNW
Apriomed AB
Gastroenterology & Urology · 90d
Cleared Jun 09, 2015
Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)
K150662 · FMI
Ypsomed AG
General Hospital · 88d
Cleared Jun 09, 2015
OASYS System
K150753 · KWP
Stryker Corporation
Orthopedic · 78d
Cleared Jun 09, 2015
extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative...
K151240 · OMP
Devon Medical Products
General & Plastic Surgery · 29d
Cleared Jun 08, 2015
VIDAS FT4
K132058 · CEC
Biomerieux S.A.
Chemistry · 705d
Cleared Jun 08, 2015
smARTrack Feeding Tube System
K142327 · KNT
Art Healthcare , Ltd.
Gastroenterology & Urology · 292d
Cleared Jun 08, 2015
Hemogrip Patch
K143466 · QSY
Remedium Technologies, Inc.
General & Plastic Surgery · 186d
Cleared Jun 08, 2015
ZX2 Laser System
K150466 · ILY
Lzr7, Inc.
Physical Medicine · 105d
Cleared Jun 08, 2015
Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti
K150643 · OVD
Centinel Spine, Inc.
Orthopedic · 88d
Cleared Jun 08, 2015
Visaris Avanse
K150725 · KPR
Visaris D.O.O. Belgrade
Radiology · 80d
Cleared Jun 08, 2015
Ensizor Endoscopic Scissors
K150939 · OCZ
Slater Endoscopy, LLC
Gastroenterology & Urology · 62d
Cleared Jun 08, 2015
BD Veritor™ System Flu A+B Assay
K151301 · PSZ
Becton, Dickinson and Company
Microbiology · 24d
Cleared Jun 07, 2015
MicroCross Catheter
K151082 · DQY
Roxwood Medical, Inc.
Cardiovascular · 46d
Cleared Jun 05, 2015
TI-OSS
K140021 · NPM
Chiyewon
Dental · 518d
Cleared Jun 05, 2015
IMED-Z FLUID STATUS MONITOR
K142503 · DSB
Intersection Medical, Inc.
Cardiovascular · 273d