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
49225–49248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102611 · LYZ
Shijiazhuang Hyland Plastic Co., Ltd.
General Hospital · 42d
Cleared Oct 21, 2010
K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK...
K102890 · FPA
Kawasumi Laboratories America, Inc.
General Hospital · 21d
Cleared Oct 20, 2010
THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012
K092256 · BTT
Smiths Medical Asd, Inc.
Anesthesiology · 449d
Cleared Oct 20, 2010
GYRUS ACMI BIOCOAG PROBE
K092571 · KNS
Gyrus Acmi, Inc.
Gastroenterology & Urology · 425d
Cleared Oct 20, 2010
EXELINT ALUMINUM HUB BLUNT NEEDLES
K101309 · LHI
Exelint International, Co.
General Hospital · 163d
Cleared Oct 20, 2010
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
K101497 · DYB
Oscor, Inc.
Cardiovascular · 141d
Cleared Oct 20, 2010
DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
K101843 · MSD
AngioDynamics, Inc.
Gastroenterology & Urology · 111d
Cleared Oct 20, 2010
CONTOURS VSP III VOLAR PLATING SYSTEM
K101936 · HRS
Orthofix, Inc.
Orthopedic · 100d
Cleared Oct 20, 2010
GALAXY LITE
K102031 · IOR
Future Mobility Healthcare, Inc.
Physical Medicine · 93d
Cleared Oct 20, 2010
JOURNEY INCLINED PLATFORM LIFT AND SUPRA CURVED INCLINE PLATFORM LIFT
K102088 · ING
Thyssenkrupp Ceteco Srl
Physical Medicine · 86d
Cleared Oct 20, 2010
NANO-CHECK AMI CTNI CARDIAC MARKER TEST
K102131 · MMI
Nano-Ditech Corporation
Chemistry · 83d
Cleared Oct 20, 2010
CARESCAPE MODEL V100 VITAL SIGNS MONITOR
K102426 · MWI
Ge Medical Systems Information...
Cardiovascular · 56d
Cleared Oct 20, 2010
NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN
K102441 · MMI
Nano-Ditech Corporation
Chemistry · 83d
Cleared Oct 20, 2010
INTRAFIX TIBIAL SHEATH
K102443 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 55d
Cleared Oct 20, 2010
VIPER SPINE SYSTEM
K102701 · NKB
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Oct 20, 2010
PIONEER CANNULATED SCREW SYSTEM
K102903 · HWC
Pioneer Surgical Technology, Inc.
Orthopedic · 20d
Cleared Oct 20, 2010
G-CATH TISSUE ANCHOR DELIVERY CATHETER
K102916 · GAT
Usgi Medical
General & Plastic Surgery · 19d
Cleared Oct 19, 2010
HRV ACQUIRE
K092809 · DRT
Wr Medical Electronics Co.
Cardiovascular · 403d
Cleared Oct 19, 2010
UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX
K093244 · DWJ
Geratherm Medical AG
Cardiovascular · 369d
Cleared Oct 19, 2010
BIO-MODULAR REVERSE SHOLDER
K093803 · PHX
Biomet Manufacturing Corp
Orthopedic · 312d
Cleared Oct 19, 2010
BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200
K101417 · FMK
Medipurpose Pte. , Ltd.
General & Plastic Surgery · 152d
Cleared Oct 19, 2010
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX...
K102023 · IYN
Shantou Institute of Ultrasonic...
Radiology · 92d
Cleared Oct 19, 2010
VASOGRAD DVT COMPRESSION GARMENT
K102732 · JOW
Compression Therapy Concepts
Cardiovascular · 27d
Cleared Oct 19, 2010
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K102737 · JOW
Covidien, LLC
Cardiovascular · 27d