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
76369–76392 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2002
WILSON-COOK ZILVER BILIARY STENT
K020788 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 58d
Cleared May 08, 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN
K020822 · JWY
Dade Behring, Inc.
Microbiology · 56d
Cleared May 08, 2002
EMIT 2000 VANCOMYCIN CALIBRATORS
K020845 · DLJ
Dade Behring, Inc.
Toxicology · 54d
Cleared May 08, 2002
ONLINE POWDER FREE, LATEX EXAMINATION GLOVES
K020865 · LYY
Apl Products Sdn. Bhd.
General Hospital · 51d
Cleared May 08, 2002
PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM
K021065 · KGO
Primus Gloves Private , Ltd.
General Hospital · 36d
Cleared May 08, 2002
OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER
K021090 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 34d
Cleared May 08, 2002
DM SLEEVE
K021102 · DWL
Emily Iker M.D., A.P.C.
General Hospital · 34d
Cleared May 08, 2002
MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD
K021148 · MNH
Depuyacromed
Orthopedic · 28d
Cleared May 08, 2002
Q-STRESS ECHO BED
K021171 · DPS
Medical Positioning, Inc.
Cardiovascular · 26d
Cleared May 08, 2002
MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B
K021300 · DSI
Philips Medical Systems
Cardiovascular · 14d
Cleared May 08, 2002
AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL
K021410 · ELW
Dentsply Intl.
Dental · 5d
Cleared May 07, 2002
STEAM STERILIZATION INTERGRATOR
K012195 · JOJ
Dana Products, Inc.
General Hospital · 298d
Cleared May 07, 2002
MAINSTREAM WATER PURIFICATION DEVICE
K012716 · NHV
Prismedical Corp.
Gastroenterology & Urology · 265d
Cleared May 07, 2002
HIGH SILVER CONVENTIONAL
K020452 · EJJ
Ab Ardent
Dental · 85d
Cleared May 07, 2002
SULTAN SPOROX TEST VIAL, MODEL 75195
K020612 · JOJ
Sultan Chemists, Inc.
General Hospital · 71d
Cleared May 07, 2002
OSSIFORM
K020720 · LYC
Unicare Biomedical, Inc.
Dental · 63d
Cleared May 07, 2002
ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
K021251 · DSI
Philips Medical Systems
Cardiovascular · 18d
Cleared May 07, 2002
TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
K021287 · DTN
Medtronic Perfusion Systems
Cardiovascular · 14d
Cleared May 07, 2002
MODIFICATION OF APEXPRO TELEMETRY SYSTEM
K021325 · MHX
General Electric Medical Systems...
Cardiovascular · 11d
Cleared May 07, 2002
MODIFICATION TO M2376A DEVICELINK SYSTEM
K021347 · MWI
Philips Medical Systems
Cardiovascular · 8d
Cleared May 06, 2002
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER...
K011690 · JAQ
Proxima Therapeutics, Inc.
Radiology · 340d
Cleared May 06, 2002
PRE-LOADED BIOSTINGER HORNET
K020377 · HWC
Linvatec Corp.
Orthopedic · 90d
Cleared May 06, 2002
PPD BALLOON DILATATION CATHETER
K020379 · KNT
Telemed Systems, Inc.
Gastroenterology & Urology · 90d
Cleared May 06, 2002
EXPANDABLE KNEE
K020381 · KRO
Biomet Orthopedics, Inc.
Orthopedic · 90d