FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
15097–15120 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 01, 1985
DISPOSABLE ECG ELECTRODE
K841944 · DRX
Bristol Medical Electronics Corp.
Cardiovascular · 294d
Cleared Mar 01, 1985
LS 5
K842037 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 294d
Cleared Mar 01, 1985
EKG TRANSMITTER MODEL 5134
K842051 · DXY
Instromedix, Inc.
Cardiovascular · 283d
Cleared Mar 01, 1985
CALCULATING CUFF INFLATOR TD312
K842067 · DXN
D. E. Hokanson, Inc.
Cardiovascular · 282d
Cleared Mar 01, 1985
ELECTROCARDIOGRAM DISPOS. ELECTRODE PAD
K842514 · DRX
Multi Biosensors, Inc.
Cardiovascular · 248d
Cleared Mar 01, 1985
ACCUTORR CSM SYSTEM
K842538 · DXN
Datascope Corp.
Cardiovascular · 246d
Cleared Mar 01, 1985
MONITORING SYSTEM M720
K842944 · DPS
Burdick Corp.
Cardiovascular · 219d
Cleared Mar 01, 1985
BRENTWOOD EZ SCAN 200 AMBULATORY ECG
K842976 · DSI
Brentwood Instruments, Inc.
Cardiovascular · 214d
Cleared Mar 01, 1985
ECG PATIENT MONITOR 302
K850155 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 45d
Cleared Mar 01, 1985
ECG PATIENT MONITOR 301
K850156 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 45d
Cleared Mar 01, 1985
CARDIO-3 CHANNEL ELECTROCARDIOGRAPH
K850454 · DPS
Zimmer Elektromedizin GmbH
Cardiovascular · 23d
Cleared Mar 01, 1985
COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM
K850656 · DXY
Cook Pacemaker Corp.
Cardiovascular · 10d
Cleared Feb 27, 1985
DISPOSABLE ECG ELECTRODES EASATRACE
K850085 · DRX
Medical Device Marketing
Cardiovascular · 47d
Cleared Feb 27, 1985
PRUITT-VASCULAR SHUNTS
K850356 · DWF
Ideas For Medicine, Inc.
Cardiovascular · 28d
Cleared Feb 25, 1985
CARDIAC CATHETERIZATION PACK
K850337 · DRE
Marwood Medical, Inc.
Cardiovascular · 28d
Cleared Feb 25, 1985
CARDIOVASCULAR SET UP
K850341 · DQO
Marwood Medical, Inc.
Cardiovascular · 28d
Cleared Feb 22, 1985
C/PES 9201, ECG STRESS TESTING SYS
K850114 · DRT
Gould, Inc.
Cardiovascular · 39d
Cleared Feb 20, 1985
ARIES MEDICAL PERFLEX PERCUTANEOUS 40CC D/L BALLOO
K844220 · DSP
Aries Medical, Inc.
Cardiovascular · 112d
Cleared Feb 20, 1985
PERIFLUX PF-2
K844631 · DPW
Medex, Inc.
Cardiovascular · 85d
Cleared Feb 20, 1985
ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON
K844856 · DRX
Bristol Medical Electronics Corp.
Cardiovascular · 68d
Cleared Feb 15, 1985
OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR
K844277 · DXG
Omikron Scientific, Ltd.
Cardiovascular · 102d
Cleared Feb 14, 1985
YKI-770 ELECTRONIC SPHYGMOMAMETER
K842318 · DXN
Yukosha Co., Inc.
Cardiovascular · 247d
Cleared Feb 14, 1985
CARDIOTOMY RESERVOIR W/FILTER
K843595 · DTN
Omnis Surgical, Inc.
Cardiovascular · 155d
Cleared Feb 14, 1985
CARDIOTOMY RESERVOIR BRS-XXX SERIES &
K843888 · DTN
Gish Biomedical, Inc.
Cardiovascular · 135d