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
38785–38808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 2014
FLASH AR
K133436 · ELW
3M Deutschland GmbH
Dental · 119d
Cleared Mar 07, 2014
SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT
K133527 · ELW
Osstem Germany GmbH
Dental · 112d
Cleared Mar 07, 2014
CHARLOTTE (TM) SNAP-OFF SCREW
K133713 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 92d
Cleared Mar 07, 2014
ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT
K134026 · PGU
Olympus Medical Systems Corp.
Gastroenterology & Urology · 67d
Cleared Mar 07, 2014
TABLE
K140093 · LLZ
Anatomage, Inc.
Radiology · 52d
Cleared Mar 07, 2014
PRO-TOE HAMMERTOE FIXATION SYSTEM
K140148 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 44d
Cleared Mar 07, 2014
OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER
K140286 · DTK
Cordis, A Johnson & Johnson Co.
Cardiovascular · 30d
Cleared Mar 07, 2014
VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR...
K140291 · IYO
Volcano Corporation
Radiology · 30d
Cleared Mar 07, 2014
NAVIGATOR HD URETERAL ACCESS SHEATH SETS
K140323 · FED
Boston Scientific
Gastroenterology & Urology · 25d
Cleared Mar 06, 2014
AIRWAY SUPPORT SYSTEM / AIRPORT
K131506 · CCK
Abeon Medical Corporation
Anesthesiology · 286d
Cleared Mar 06, 2014
BREATHE NIOV VENTILATION SYSTEM
K131562 · ONZ
Breathe Technologies
Anesthesiology · 280d
Cleared Mar 06, 2014
CATHETER INTRODUCER SHEATH
K131627 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 275d
Cleared Mar 06, 2014
AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
K131750 · CGA
Apex BioTechnology Corp.
Chemistry · 265d
Cleared Mar 06, 2014
CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM,...
K131912 · BTT
Teleflex, Inc.
Anesthesiology · 253d
Cleared Mar 06, 2014
N-FORCE FIXATION SYSTEM
K132244 · HWC
Innovision, Inc.
Orthopedic · 231d
Cleared Mar 06, 2014
MICROTABLE SYSTEM
K132611 · HAW
Fred Haer Company, Inc.
Neurology · 198d
Cleared Mar 06, 2014
UCP MULTI-DRUG TEST KEY CUPS
K132812 · DKZ
Ucp Biosciences, Inc.
Toxicology · 178d
Cleared Mar 06, 2014
ZEDVIEW
K133022 · LLZ
Lexi Co., Ltd.
Radiology · 161d
Cleared Mar 06, 2014
APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
K133036 · MBI
Amendia, Inc.
Orthopedic · 161d
Cleared Mar 06, 2014
FLASH BITE
K133400 · ELW
3M Espe AG
Dental · 120d
Cleared Mar 06, 2014
ELITE IBF
K133459 · MAX
Innova Spinal Technologies, LLC
Orthopedic · 114d
Cleared Mar 06, 2014
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH...
K133754 · GWM
Integra LifeSciences Corporation
Neurology · 87d
Cleared Mar 06, 2014
OPTIGLAZE COLOR
K133836 · EBD
GC America, Inc.
Dental · 78d
Cleared Mar 06, 2014
MODEL-BASED RSA SOFTWARE
K133966 · LLZ
Halifax Biomedical, Inc.
Radiology · 72d