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
40585–40608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 2013
INTEL-GE CARE INNOVATIONS CONNECT RCM
K130821 · DRG
Intel-Ge Care Innovations, LLC
Cardiovascular · 137d
Cleared Aug 09, 2013
FACET SCREW SYSTEM
K130863 · MRW
Spinal USA
Orthopedic · 134d
Cleared Aug 09, 2013
ACCU-CHEK AVIVA PLUS TEST STRIP
K131029 · NBW
Roche Diagnostics Operations, Inc.
Chemistry · 119d
Cleared Aug 09, 2013
ARTHROCARE HEAD AND NECK COBLATION WAND
K131205 · GEI
ArthroCare Corporation
General & Plastic Surgery · 102d
Cleared Aug 09, 2013
ICONACY I-HIP SYSTEM
K131279 · LPH
Iconacy Orthopedic Implants, LLC
Orthopedic · 95d
Cleared Aug 09, 2013
LIVE VIEW PANEL (LVP)
K131415 · OLV
Neurotronics, Inc.
Neurology · 85d
Cleared Aug 09, 2013
ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
K131419 · NBW
I-Sens, Inc.
Chemistry · 85d
Cleared Aug 09, 2013
LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
K131441 · LGD
DiaSorin, Inc.
Microbiology · 81d
Cleared Aug 09, 2013
CORE PEDICLE SCREW SYSTEM
K131522 · MNI
Core-Nexus
Orthopedic · 73d
Cleared Aug 09, 2013
PRODESSE PROFLU+ ASSAY
K132129 · OCC
Gen-Probe Prodesse, Inc.
Microbiology · 30d
Cleared Aug 09, 2013
CAPSURE PS SYSTEM
K132154 · MNI
Spine Wave, Inc.
Orthopedic · 28d
Cleared Aug 09, 2013
QLAB QUANTIFICATION SOFTWARE
K132165 · LLZ
Philips Ultrasound, Inc.
Radiology · 28d
Cleared Aug 09, 2013
METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT
K132226 · HRS
Merete Medical GmbH
Orthopedic · 23d
Cleared Aug 08, 2013
COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY
K121610 · PDJ
Roche Diagnostics Operations
Chemistry · 433d
Cleared Aug 08, 2013
PEDIGUARD NERVE DETECTOR SYSTEM
K123390 · PDQ
Spineguard S.A.
Neurology · 279d
Cleared Aug 08, 2013
MP VIAL ADAPTER 13MM
K130179 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 195d
Cleared Aug 08, 2013
PANPAC VAGINAL DILATORS
K130273 · HDX
Panpac Medical Corporation
Obstetrics & Gynecology · 185d
Cleared Aug 08, 2013
EXPANDABLE LUMBAR INTERBODY SYSTEM
K130820 · MAX
Nu Vasive, Incorporated
Orthopedic · 136d
Cleared Aug 08, 2013
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN
K130846 · LZA
Industrial Clothings, Ltd.
General Hospital · 134d
Cleared Aug 08, 2013
CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM
K131538 · MNH
Captiva Spine
Orthopedic · 71d
Cleared Aug 08, 2013
PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
K131674 · JEY
Biomet Microfixation
Dental · 62d
Cleared Aug 08, 2013
NMI PORT II CATHETER
K131694 · LJT
Navilyst Medical, Inc.
General Hospital · 59d
Cleared Aug 08, 2013
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR,...
K131744 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 56d
Cleared Aug 08, 2013
METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM
K131759 · HRS
Tianjin Walkman Biomaterial Co., Ltd.
Orthopedic · 52d