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
81049–81072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2001
TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM
K010011 · ITI
Accelerated Rehab Designs, Inc.
Physical Medicine · 10d
Cleared Jan 12, 2001
MAXIM KNEE SYSTEM
K010027 · JWH
Biomet, Inc.
Orthopedic · 9d
Cleared Jan 11, 2001
COSMED QUARK
K001174 · BZC
Cosmed Srl
Anesthesiology · 275d
Cleared Jan 11, 2001
OUTBACK CATHETER
K001577 · DQY
Lumend, Inc.
Cardiovascular · 234d
Cleared Jan 11, 2001
PENILE CONSTRICTOR RING
K001859 · LKY
Basic Solutions, LLC
Gastroenterology & Urology · 206d
Cleared Jan 11, 2001
MICRUS MICROCOIL DELIVERY SYSTEM, MDS03
K002056 · HCG
Micrus Corp.
Neurology · 189d
Cleared Jan 11, 2001
RADIANALYZER, MODEL 12710
K002067 · DSK
Radi Medical Systems AB
Cardiovascular · 188d
Cleared Jan 11, 2001
MICROSTREAM EXTERNAL BATTERY CHARGER
K002163 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 177d
Cleared Jan 11, 2001
PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES
K002381 · FMF
Pentaferte, S.R.L.
General Hospital · 160d
Cleared Jan 11, 2001
LACTOSORB SCREW ANCHOR
K003273 · MAI
Biomet, Inc.
Orthopedic · 85d
Cleared Jan 11, 2001
FILAC FAS TEMP ELECTRONIC THERMOMETER
K003313 · FLL
The Kendall Company
General Hospital · 80d
Cleared Jan 11, 2001
BURN JEL PLUS
K003396 · MGQ
Water-Jel Technologies, LLC
General & Plastic Surgery · 71d
Cleared Jan 11, 2001
CARE PROVIDER STATION ADDITION OF WEIGHT SCALE
K003485 · DQD
Cybercare Technologies, Inc.
Cardiovascular · 85d
Cleared Jan 11, 2001
TAXOL ADMINISTRATION SET
K003513 · FPA
Icu Medical, Inc.
General Hospital · 58d
Cleared Jan 11, 2001
AVANTE CURELIGHT
K003683 · EBZ
Jeneric/Pentron, Inc.
Dental · 43d
Cleared Jan 11, 2001
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
K003848 · JEC
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jan 11, 2001
MULTITRACK ANGIOGRAPHIC CATHETER
K003902 · DQO
NuMED, Inc.
Cardiovascular · 23d
Cleared Jan 11, 2001
NUMED GHOST II PTA CATHETERS
K003972 · LIT
NuMED, Inc.
Cardiovascular · 20d
Cleared Jan 10, 2001
TRIAD II MODULAR TOTAL HIP SYSTEM
K003199 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Jan 10, 2001
FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II
K003202 · GEX
Altus Medical
General & Plastic Surgery · 90d
Cleared Jan 10, 2001
U2 HIP STEM, TI POROUS COATED
K003237 · LPH
United Orthopedic Corp.
Orthopedic · 85d
Cleared Jan 10, 2001
BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G,...
K003603 · EJT
Jelenko Co.
Dental · 50d
Cleared Jan 09, 2001
SYNTHES (USA) RESORBABLE TACK SYSTEM
K000560 · JEY
Synthes (Usa)
Dental · 326d
Cleared Jan 09, 2001
VENODYNE DVT ADVANTAGE MODEL 610
K001802 · JOW
Microtek Medical, Inc.
Cardiovascular · 209d