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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
53833–53856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2009
CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES
K090186 · MAI
Linvatec Corp.
Orthopedic · 74d
Cleared Apr 10, 2009
ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
K090189 · FPA
Icu Medical, Inc.
General Hospital · 74d
Cleared Apr 10, 2009
EXTREME 4X4-X8 POWER WHEELCHAIR
K090350 · ITI
Vestil Manufacturing Corp.
Physical Medicine · 58d
Cleared Apr 10, 2009
HYDROFRAME (HES)
K090357 · HCG
MicroVention, Inc.
Neurology · 57d
Cleared Apr 10, 2009
I OPEN 0.5T
K090873 · LNH
Beijing Wandong Medical Equipment...
Radiology · 10d
Cleared Apr 09, 2009
CAMBRIA
K082309 · ODP
Seaspine, Inc.
Orthopedic · 239d
Cleared Apr 09, 2009
PAPCONE
K083012 · HHT
Otto Bock Pur Life Science GmbH
Obstetrics & Gynecology · 182d
Cleared Apr 09, 2009
BCI WW1020 PULSE OXIMETER, MODEL WW1020
K083705 · DQA
Smiths Medical Pm, Inc.
Anesthesiology · 115d
Cleared Apr 09, 2009
TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440...
K083861 · ETY
Interacoustics AS
Ear, Nose, Throat · 106d
Cleared Apr 09, 2009
CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE
K090014 · DXQ
Caremate Medical Device Co., Ltd.
Cardiovascular · 97d
Cleared Apr 09, 2009
AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9
K090043 · CGA
Apex BioTechnology Corp.
Chemistry · 92d
Cleared Apr 09, 2009
EMINENT SPINE INTERBODY FUSION SYSTEM
K090064 · MAX
Eminent Spine
Orthopedic · 90d
Cleared Apr 09, 2009
AEROCHAMBER MINI VENTILATION CHAMBER
K090065 · CAF
Trudell Medical Intl.
Anesthesiology · 90d
Cleared Apr 09, 2009
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
K090663 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 08, 2009
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
K082251 · DCF
Beckman Coulter, Inc.
Chemistry · 243d
Cleared Apr 08, 2009
IMMERSION HYDROBATH
K082951 · ILJ
Arjo Hospital Equipment AB
Physical Medicine · 187d
Cleared Apr 08, 2009
PROWICK
K083007 · FRO
Arthrex, Inc.
General & Plastic Surgery · 182d
Cleared Apr 08, 2009
INCISIVE FAMILY OF INPULSE ND:YAG LASERS
K083215 · GEX
Incisive, LLC
General & Plastic Surgery · 159d
Cleared Apr 08, 2009
AVC A/H5N1 FLU TEST
K083278 · OMS
Arbor Vita Corportation
Microbiology · 152d
Cleared Apr 08, 2009
PIEZOSURGERY MEDICAL
K083284 · JDX
Piezosurgery S.R.L.
Orthopedic · 152d
Cleared Apr 08, 2009
BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED
K083483 · OLO
Brainlab AG
Orthopedic · 135d
Cleared Apr 08, 2009
ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
K090057 · NBW
Acon Laboratories Co.
Chemistry · 90d
Cleared Apr 08, 2009
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA...
K090253 · QEZ
Possis Medical, Inc.
Cardiovascular · 65d
Cleared Apr 08, 2009
DIGDOP ULTRASOUND SYSTEM
K090465 · ITX
The Newman Group, LLC
Radiology · 44d