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
49825–49848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 2010
SLENDERTONE FLEX MAX, MODEL 517 US
K100556 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 154d
Cleared Aug 02, 2010
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS...
K100741 · PHX
Encore Medical, L.P.
Orthopedic · 139d
Cleared Aug 02, 2010
THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
K100819 · DYB
Onset Medical Corporation
Cardiovascular · 132d
Cleared Aug 02, 2010
RANGE SPINAL SYSTEM
K100851 · MNI
K2m, Inc.
Orthopedic · 129d
Cleared Aug 02, 2010
INTRAVSCULAR ADMINISTRATION SET
K100946 · FPA
Terumo Europe N.V.
General Hospital · 118d
Cleared Aug 02, 2010
NEODENT IMPLANT SYSTEM
K101207 · DZE
Jjgc Industria E Comercio DE...
Dental · 94d
Cleared Aug 02, 2010
SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM
K101409 · MED
STERIS Corporation
General Hospital · 75d
Cleared Aug 02, 2010
MILTEX THOMPSON CASSETTES
K101653 · KCT
Miltex, Inc.
General Hospital · 52d
Cleared Aug 02, 2010
EXACTECH EQUINOXE, PLATFORM FRACTURE STEM
K101909 · PHX
Exactech, Inc.
Orthopedic · 25d
Cleared Aug 02, 2010
OPTETRAK LOGIC COMBINATION TIBIAL TRAY
K101981 · JWH
Exactech, Inc.
Orthopedic · 19d
Cleared Jul 30, 2010
ARTHREX BIOWIRE
K091018 · GAS
Arthrex, Inc.
General & Plastic Surgery · 477d
Cleared Jul 30, 2010
EMS PIEZON MASTER 700
K093000 · ELC
E.M.S Electro Medical Systems S.A
Dental · 305d
Cleared CT Jul 30, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008
K101010 · DXN
Andon Health Co, Ltd.
Cardiovascular · 109d
Cleared Jul 30, 2010
VEGA KNEE SYSTEM
K101281 · JWH
Aesculap Implant System, Inc.
Orthopedic · 85d
Cleared Jul 30, 2010
ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM...
K101296 · LZO
Zimmer, Inc.
Orthopedic · 81d
Cleared Jul 30, 2010
VIGILANT EEG MONITOR MODEL VIGILANT 2.0
K101386 · GWQ
Infinite Biomedical Technologies, LLC
Neurology · 73d
Cleared Jul 30, 2010
OPTIBOND XTR
K101423 · KLE
Kerr Corporation
Dental · 71d
Cleared Jul 30, 2010
AMIGO CLASSIC FD
K101507 · INI
Amigo Mobility Intl., Inc.
Physical Medicine · 59d
Cleared Jul 29, 2010
BIOGENNIX RPC
K093342 · MQV
Biogennix, LLC
Orthopedic · 276d
Cleared Jul 29, 2010
IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY
K093489 · FPA
Rymed Technologies, Inc.
General Hospital · 261d
Cleared Jul 29, 2010
GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
K093608 · FIP
Gambro Renal Products, Inc.
Gastroenterology & Urology · 251d
Cleared Jul 29, 2010
FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION
K093724 · JJX
Taidoc Technology Corporation
Chemistry · 238d
Cleared Jul 29, 2010
ZOLL PROPAQ MD
K100654 · LDD
Zoll Medical Corporation, World Wide...
Cardiovascular · 143d
Cleared Jul 29, 2010
ENDOSKELETON TC
K100889 · ODP
Titan Spine, LLC
Orthopedic · 120d