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
72841–72864 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 2003
AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA
K030741 · MID
Hycor Biomedical , Ltd.
Immunology · 52d
Cleared May 01, 2003
LITTLE COACH
K030759 · INI
Wheelchair & Scooter Express
Physical Medicine · 51d
Cleared May 01, 2003
PASCO MIC AND MIC/ID PANELS
K030933 · JWY
Pasco Laboratories, Inc.
Microbiology · 37d
Cleared May 01, 2003
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
K031162 · JDQ
Smith & Nephew, Inc.
Orthopedic · 17d
Cleared May 01, 2003
MEDIPALM-20
K031202 · OLV
Braebon Medical Corp.
Neurology · 15d
Cleared Apr 30, 2003
HEMO-STREAM HEMODIALYSIS CATHETER SET
K023847 · MSD
Rex Medical
Gastroenterology & Urology · 162d
Cleared Apr 30, 2003
'RAPIDTEC'-5M-MULTIPLE DIP TEST
K023869 · DJR
American Bio Medica Corp.
Toxicology · 161d
Cleared Apr 30, 2003
ATHENA PELVIC MUSCLE TRAINER
K023905 · KPI
Athena Feminine Technologies, Inc.
Gastroenterology & Urology · 159d
Cleared Apr 30, 2003
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K030415 · LJS
AngioDynamics, Inc.
General Hospital · 82d
Cleared Apr 30, 2003
CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE
K030451 · FBK
Carbon Medical Technologies, Inc.
Gastroenterology & Urology · 78d
Cleared Apr 30, 2003
CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS
K030690 · LMC
Codonics, Inc.
Radiology · 56d
Cleared Apr 30, 2003
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
K031185 · FRN
Abbott Laboratories
General Hospital · 15d
Cleared Apr 30, 2003
AQUASENS FLUID MONITORING SYSTEM
K031213 · HIG
Davol, Inc.
Obstetrics & Gynecology · 13d
Cleared Apr 29, 2003
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
K020418 · MEA
P.T. Greenleaf
General Hospital · 446d
Cleared Apr 29, 2003
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
K020421 · MEA
Hennig Enterprises Europe Srl
General Hospital · 446d
Cleared Apr 29, 2003
CARBODISSECTING ENDOSCOPE
K020925 · DWX
Endo Surgical Devices, Inc.
Cardiovascular · 404d
Cleared Apr 29, 2003
ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR
K021174 · DSB
Imagyn Surgical
Cardiovascular · 382d
Cleared Apr 29, 2003
X O ODONTOSURGE 4
K023672 · EKZ
Xo Care A/S
Dental · 179d
Cleared Apr 29, 2003
SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE...
K030133 · EBF
Dentalez Group
Dental · 105d
Cleared Apr 29, 2003
FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC...
K030303 · GEH
Cryocath Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Apr 29, 2003
DEROYAL DRAPES, STERILE, NON-STERILE
K030365 · KKX
Deroyal Industries, Inc.
General Hospital · 84d
Cleared Apr 29, 2003
SYNCHRON SYSTEMS OPIATE REAGENT
K031002 · DJG
Beckman Coulter, Inc.
Toxicology · 29d
Cleared Apr 28, 2003
MICROALBUMIN REAGENT SET AND CALIBRATORS
K023860 · DDZ
Pointe Scientific, Inc.,
Chemistry · 159d
Cleared Apr 28, 2003
CHROMOCHECK ANTITHROMBIN 25
K023991 · JBQ
Precision Biologic
Hematology · 146d