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
51865–51888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 2009
ASCENSION CANNULATED SCREW SYSTEM
K092440 · HWC
Ascension Orthopedics, Inc.
Orthopedic · 87d
Cleared Nov 05, 2009
IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140
K092461 · OCX
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 86d
Cleared Nov 05, 2009
SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM
K092463 · DTQ
Sorin Group Deutschland GmbH
Cardiovascular · 86d
Cleared Nov 05, 2009
SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM
K092504 · GCJ
Surgiquest, Inc.
General & Plastic Surgery · 83d
Cleared Nov 05, 2009
HEADWAY 21 MICROCATHETER, MODEL: MC212150S
K093160 · DQY
MicroVention, Inc.
Cardiovascular · 30d
Cleared Nov 05, 2009
MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
K093187 · FDF
Avantis Medical Systems, Inc.
Gastroenterology & Urology · 27d
Cleared Nov 05, 2009
ALEXIS LAPAROSCOPIC SYSTEM
K093296 · KGW
Applied Medical Resources Corp.
General & Plastic Surgery · 15d
Cleared Nov 04, 2009
GUIDELINER CATHETER, MODELS 5571, 5572, 5573
K091750 · DQY
Vascular Solutions, Inc.
Cardiovascular · 141d
Cleared Nov 04, 2009
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE
K092072 · LZA
Gx Corporation Sdn Bhd
General Hospital · 119d
Cleared Nov 04, 2009
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K092313 · MEA
B.Braun Medical, Inc.
General Hospital · 97d
Cleared Nov 04, 2009
LIQUICORD
K092384 · MVL
Centrix, Inc.
Dental · 91d
Cleared Nov 04, 2009
ABG II MODULAR HIP STEM
K092406 · MEH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Nov 04, 2009
AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000
K092490 · FLE
STERIS Corporation
General Hospital · 83d
Cleared Nov 04, 2009
GATOR CLIPSEAL PLUG
K092563 · DTL
Vascular Solutions, Inc.
Cardiovascular · 76d
Cleared Nov 04, 2009
EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
K092657 · CAZ
Smiths Medical Asd, Inc.
Anesthesiology · 68d
Cleared Nov 04, 2009
ENGAGE TR INTRODUCER
K093130 · DYB
St Jude Medical
Cardiovascular · 30d
Cleared Nov 04, 2009
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093170 · MNI
Spineart
Orthopedic · 28d
Cleared Nov 04, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093270 · LYZ
Tangshan Excellence Glove Co., Ltd.
General Hospital · 16d
Cleared Nov 04, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093276 · LYZ
Tangshan Kangyuan Glove Co., Ltd.
General Hospital · 16d
Cleared Nov 03, 2009
EPICARE-DUO LASER SYSTEM
K091625 · GEX
Light Age, Inc.
General & Plastic Surgery · 153d
Cleared Nov 03, 2009
INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90
K091927 · DSI
Philips Medizinsysteme Boeblingen...
Cardiovascular · 126d
Cleared Nov 03, 2009
ELECSYS PRECICONTROL THYROAB
K092320 · JJY
Roche Diagnostics
Chemistry · 91d
Cleared Nov 03, 2009
MODEL 220 PATIENT MAGNET
K092364 · DTG
Cyberonics, Inc.
Cardiovascular · 90d
Cleared Nov 03, 2009
REPROCESSED PULSE OXIMETER SENSORS
K092368 · NLF
Sterilmed, Inc.
Anesthesiology · 90d