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
141817–141840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 1987
MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES
K863369 · DRX
Tdk Corp.
Cardiovascular · 166d
Cleared Jan 06, 1987
LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.
K863535 · DPS
Computerized Medical Systems, Inc.
Cardiovascular · 117d
Cleared Jan 06, 1987
MEDTRONIC MODEL 5013
K863536 · DTB
Medtronic Vascular
Cardiovascular · 117d
Cleared Jan 06, 1987
URESIL SUBCLAVIAN CATHETER
K863684 · DQY
Uresil Corp.
Cardiovascular · 109d
Cleared Jan 06, 1987
COMPUTER CONTROLLED EXTENSION (CCX)
K863705 · IYE
Varian Assoc., Inc.
Radiology · 105d
Cleared Jan 06, 1987
ACCUSAT
K863855 · DQA
Datascope Corp.
Anesthesiology · 96d
Cleared Jan 06, 1987
DISPOSABLE ECG MONITORING ELECTRODE
K863904 · DRX
Clinical Data, Inc.
Cardiovascular · 91d
Cleared Jan 06, 1987
MODIFICATION TO DYNASCOPE SERIES MONITORS
K863914 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 90d
Cleared Jan 06, 1987
CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM
K863916 · DQY
Cardio-Vascular Innovations, Inc.
Cardiovascular · 90d
Cleared Jan 06, 1987
CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.
K863917 · DYB
Cardio-Vascular Innovations, Inc.
Cardiovascular · 90d
Cleared Jan 06, 1987
DUFFY BOLUS INJECTOR
K863936 · IWR
Viox Corp.
Radiology · 89d
Cleared Jan 06, 1987
PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)
K864062 · DXE
Ideas For Medicine, Inc.
Cardiovascular · 78d
Cleared Jan 06, 1987
PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290
K864153 · DTB
Pace Medical
Cardiovascular · 75d
Cleared Jan 06, 1987
SHEAR FORCE GAUGE
K864330 · DXE
American Edwards Laboratories
Cardiovascular · 63d
Cleared Jan 06, 1987
TRI-LOCK LONG STEM MODULAR NECK
K864331
Depuy, Inc.
Orthopedic · 63d
Cleared Jan 06, 1987
MODIFIED PEEL-AWAY INTRODUCER SET LINE
K864352 · DYB
Quinton, Inc.
Cardiovascular · 63d
Cleared Jan 06, 1987
TRACHEOBRONCHIAL SUCTION CATHETER
K864468 · BSY
Sheridan Catheter Corp.
Anesthesiology · 55d
Cleared Jan 06, 1987
MODIFIED RLV-2100 B
K864503 · DWD
American Omni Medical, Inc.
Cardiovascular · 53d
Cleared Jan 06, 1987
TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110
K864535 · BSY
Concord Laboratories, Inc.
Anesthesiology · 50d
Cleared Jan 06, 1987
CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD
K864601 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 43d
Cleared Jan 06, 1987
MODIFIED ESCHMANN DILATATION CATHETER
K864637
Eschmann Bros. & Walsh , Ltd.
Cardiovascular · 48d
Cleared Jan 06, 1987
ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD
K864640 · DTB
Cordis Corp.
Cardiovascular · 41d
Cleared Jan 06, 1987
SALT CREEK P.I. TRAY
K864682
Salt Creek Medical Technologies
Cardiovascular · 35d
Cleared Jan 06, 1987
MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP
K864738 · DTB
Intermedics, Inc.
Cardiovascular · 33d