FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
10249–10272 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 03, 1997
FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
K963248 · DYG
J-Lloyd Medical, Inc.
Cardiovascular · 168d
Cleared Feb 03, 1997
FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS...
K964662 · DXC
Rmds, Inc.
Cardiovascular · 74d
Cleared Jan 31, 1997
CHASE VESSEL OCCLUDER
K964390 · MJN
Chase Medical, Inc.
Cardiovascular · 88d
Cleared Jan 30, 1997
OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)
K964445 · DWS
Dlp, Inc.
Cardiovascular · 85d
Cleared Jan 29, 1997
PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM
K922668 · MHX
Colin Medical Instruments Corp.
Cardiovascular · 1700d
Cleared Jan 29, 1997
PATHFINDER
K955802 · DRF
Cardima, Inc.
Cardiovascular · 404d
Cleared Jan 29, 1997
GYRO TIP EP CATHETER
K955847 · DRF
Cardiac Assist Devices, Inc.
Cardiovascular · 400d
Cleared Jan 29, 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K962291 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 229d
Cleared Jan 28, 1997
SOF. PRESS EPC 51 SYSTEM
K963067 · JOW
Gaymar Industries, Inc.
Cardiovascular · 174d
Cleared Jan 28, 1997
TORQUE DEVICE
K964352 · DQX
B.Braun Medical, Inc.
Cardiovascular · 88d
Cleared Jan 28, 1997
TRANSEND GUIDEWIRE
K964611 · DQX
Boston Scientific Corp
Cardiovascular · 71d
Cleared Jan 27, 1997
ANEROID AND MERCURIAL SPHYGMOMANOMETERS
K962655 · DXQ
American Diagnostic Corp.
Cardiovascular · 203d
Cleared Jan 27, 1997
HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO...
K962854 · LOS
Cardio Control BV
Cardiovascular · 189d
Cleared Jan 27, 1997
JOBST ATHROMBIC PUMP SYSTEM 2100
K963929 · JOW
Jobst A Beiersdorf Co.
Cardiovascular · 144d
Cleared Jan 23, 1997
PERFORMR SERIES EP DIAGNOSTIC CATHETERS
K964272 · DRF
Medtronic Cardiorhythm
Cardiovascular · 90d
Cleared Jan 22, 1997
BRENTWOOD PC-ECG
K955023 · DSI
Brentwood Medical Products, Inc.
Cardiovascular · 447d
Cleared Jan 22, 1997
HEMASHIELD VANTAGE (VASCULAR GRAFT
K961847 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 254d
Cleared Jan 22, 1997
ACS HI-TORQUE IRON MAN GUIDE WIRE
K963702 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 128d
Cleared Jan 22, 1997
HEARTPORT ENDOCORONARY SINUS CATHETR
K964248 · DWF
Heartport, Inc.
Cardiovascular · 90d
Cleared Jan 17, 1997
SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
K962404 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 210d
Cleared Jan 15, 1997
700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES
K964991 · MKJ
Cardiotronics Systems, Inc.
Cardiovascular · 33d
Cleared Jan 14, 1997
SEGUE INFUSION CATHETER
K964154 · KRA
Interventional Innovations Corp.
Cardiovascular · 90d
Cleared Jan 13, 1997
GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET
K960511 · DWJ
Gibeck, Inc.
Cardiovascular · 343d
Cleared Jan 13, 1997
VERSA-CATH ARTERIAL CATHETER
K961883 · DXE
Ideas For Medicine, Inc.
Cardiovascular · 243d