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
9433–9456 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 01, 1999
NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR...
K990338 · DXN
Physio-Control Corp.
Cardiovascular · 210d
Cleared Sep 01, 1999
CUFF-ABLE PLUS
K990412 · DXQ
Vital Signs, Inc.
Cardiovascular · 203d
Cleared Sep 01, 1999
A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE
K992808 · DXN
A&D Medical Div.
Cardiovascular · 12d
Cleared Aug 31, 1999
CARD GUARD, MODEL CG-6550
K990478 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 196d
Cleared Aug 31, 1999
EQUINOX OCCLUSION BALLOON SYSTEM
K990487 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 196d
Cleared Aug 31, 1999
HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
K992636 · DXJ
Hewlett-Packard Co.
Cardiovascular · 25d
Cleared Aug 30, 1999
ENDOSONICS TRAK BACK DEVICE
K990271 · DQX
Endosonics Corp.
Cardiovascular · 214d
Cleared Aug 30, 1999
TELEMEDICINE 2000
K992164 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 66d
Cleared Aug 23, 1999
K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
K991007 · MKJ
Katecho, Inc.
Cardiovascular · 150d
Cleared Aug 23, 1999
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
K992123 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 61d
Cleared Aug 20, 1999
ADVANTA GRAFT
K992441 · DYF
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Aug 20, 1999
ADVANTA GRAFT
K992443 · DSY
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Aug 19, 1999
JOSTRA HL-20 TWIN PUMP
K984338 · DPW
Jostra Bentley
Cardiovascular · 259d
Cleared Aug 19, 1999
MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC...
K991735 · LOS
General Electric Medical Systems...
Cardiovascular · 90d
Cleared Aug 19, 1999
ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR
K992413 · DRT
Medical Data Electronics
Cardiovascular · 30d
Cleared Aug 18, 1999
ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
K992411 · DRT
Medical Data Electronics
Cardiovascular · 29d
Cleared Aug 10, 1999
CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
K984214 · DXC
Cordis Neurovascular, Inc.
Cardiovascular · 259d
Cleared Aug 10, 1999
KELLER VITAL SIGNS MONITOR, KMS 890+
K990648 · DXN
Keller Medical Specialties Products,...
Cardiovascular · 162d
Cleared Aug 10, 1999
RADIFOCUS OPTITORQUE
K992051 · DQO
Terumo Medical Corp.
Cardiovascular · 53d
Cleared Aug 05, 1999
HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A
K991871 · MKJ
Hewlett-Packard Co.
Cardiovascular · 65d
Cleared Aug 03, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100
K992387 · DPW
Rossmax International , Ltd.
Cardiovascular · 15d
Cleared Aug 03, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200
K992388 · DPW
Rossmax International , Ltd.
Cardiovascular · 15d
Cleared Jul 30, 1999
LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB,...
K983802 · MJN
Lucas Medical, Inc.
Cardiovascular · 275d
Cleared Jul 30, 1999
AVE GL-1 GUIDING CATHETER
K984482 · DQY
Arterial Vascular Engineering...
Cardiovascular · 226d