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
49057–49080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 2010
IMPROVIS IMAGING SYSTEM
K101654 · LLZ
American Dental Partners, Inc.
Radiology · 152d
Cleared Nov 10, 2010
THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301
K101912 · FLL
Hubdic Co., Ltd.
General Hospital · 124d
Cleared Nov 10, 2010
PARCUS PEEK CF PUSH-IN SUTURE ANCHOR
K102162 · HWC
Parcus Medical, LLC
Orthopedic · 100d
Cleared Nov 10, 2010
NIVO NEBULIZER SYSTEM
K102240 · CAF
Aerogen (Ireland), Ltd.
Anesthesiology · 93d
Cleared Nov 10, 2010
ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS
K102445 · HEB
Rostam , Ltd.
Obstetrics & Gynecology · 76d
Cleared Nov 10, 2010
EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD,...
K103012 · LZO
Exactech, Inc.
Orthopedic · 29d
Cleared Nov 10, 2010
V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE
K103052 · GAT
Covidien, LLC
General & Plastic Surgery · 27d
Cleared Nov 10, 2010
VONFLEX HEAVY, VINFLEX LIGHT
K103164 · ELW
Vericom Co., Ltd.
Dental · 14d
Cleared Nov 10, 2010
BLOOD SAMPLING SET
K103165 · FPA
Acacia, Inc.
General Hospital · 14d
Cleared Nov 10, 2010
SILK'N FLASH N GO
K103184 · OHT
Home Skinovations , Ltd.
General & Plastic Surgery · 12d
Cleared Nov 09, 2010
RANDOX METABOLITE (EDDP) ASSAY
K092258 · DJR
Randox Laboratories, Ltd.
Toxicology · 469d
Cleared Nov 09, 2010
INTERFACE
K092541 · MQV
Biostructures
Orthopedic · 447d
Cleared Nov 09, 2010
MODIFICATION TO: OASYS SYSTEM
K101183 · KWP
Stryker Spine
Orthopedic · 195d
Cleared Nov 09, 2010
EMATRIX CO2
K101321 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 182d
Cleared Nov 09, 2010
DPL NUVE
K101382 · OHS
Led Technologies, LLC
General & Plastic Surgery · 176d
Cleared Nov 09, 2010
LOCKING COMPRESSION PLATE
K101400 · HRS
Changzhou Orthmed Medical Instrument...
Orthopedic · 175d
Cleared Nov 09, 2010
ATRAUMATIC VASCULAR CLAMPS
K102048 · DXC
Geomed Medizin-Technik GmbH & Co. KG
Cardiovascular · 111d
Cleared Nov 09, 2010
KIRSCHNER WIRES, STEINMAN PINS
K102215 · HTY
Evergreen Orthopedic Research Lab
Orthopedic · 95d
Cleared Nov 09, 2010
CARE ZY5BA OXYGEN CONCENTRATOR
K102245 · CAW
Foshan Care Medical Technology Co., Ltd.
Anesthesiology · 92d
Cleared Nov 09, 2010
MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS
K102344 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 83d
Cleared Nov 09, 2010
SEQURE SNARE SYSTEM
K102484 · MMX
Lifetech Scientific (Shenzhen) Co., Ltd.
Cardiovascular · 71d
Cleared Nov 09, 2010
KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM
K102666 · KKX
Kimberly-Clark Corp.
General Hospital · 55d
Cleared Nov 09, 2010
ELECTRONIC BLOOD PRESURE MONITOR
K102988 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 34d
Cleared Nov 09, 2010
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
K103003 · JXG
Aesculap, Inc.
Neurology · 28d