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
13969–13992 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 07, 1987
NAMIC COURNAND STYLE INTRODUCER NEEDLE
K871377 · DRC
North American Instrument Corp.
Cardiovascular · 30d
Cleared May 06, 1987
VASOPULSE(TM)/MODEL 5000
K863803 · JOM
Sonicaid, Inc.
Cardiovascular · 219d
Cleared May 06, 1987
ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD
K864690 · DRX
Multi Biosensors, Inc.
Cardiovascular · 155d
Cleared May 06, 1987
CORDAY CORONARY SINUS INFUSION CATHETER
K865074 · DQY
Retroperfusion Systems, Inc.
Cardiovascular · 128d
Cleared May 06, 1987
MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER
K870301 · DRS
Medex, Inc.
Cardiovascular · 98d
Cleared May 06, 1987
SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR
K870829 · DTN
3M Health Care, Sarns
Cardiovascular · 64d
Cleared May 06, 1987
IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM
K870934 · DXG
Integrated Medical Systems, Inc.
Cardiovascular · 58d
Cleared May 06, 1987
ONGUARD 1000, CATALOG #043611-000 & 043611-001
K870976 · DTQ
Cobe Laboratories, Inc.
Cardiovascular · 57d
Cleared May 06, 1987
IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL
K871333 · DTB
Medtronic Vascular
Cardiovascular · 33d
Cleared May 06, 1987
NAMIC SELDINGER INTRODUCER NEEDLE
K871378 · DRC
North American Instrument Corp.
Cardiovascular · 29d
Cleared May 06, 1987
NAMIC ONE PART INTRODUCER NEEDLE
K871382 · DRC
North American Instrument Corp.
Cardiovascular · 29d
Cleared Apr 28, 1987
MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20
K870067 · DQY
Vygon Corp.
Cardiovascular · 110d
Cleared Apr 28, 1987
THORASTAT ATR-XXXX
K870792 · DTP
Gish Biomedical, Inc.
Cardiovascular · 61d
Cleared Apr 27, 1987
CENTRAL VENOUS CATHETER
K870075 · DQY
Bd Becton Dickinson Vacutainer...
Cardiovascular · 109d
Cleared Apr 27, 1987
#014160-TAB TUBING ROTATOR ADAPTOR
K870325 · DTL
Clinical Connections, Inc.
Cardiovascular · 89d
Cleared Apr 27, 1987
VASCATH VASCULAR CATHETER PLACEMENT KIT
K870542 · DYB
Titan Medical, Inc.
Cardiovascular · 77d
Cleared Apr 27, 1987
BPA CARDIOVASCULAR PRESSURE AMPLIFIER
K870783 · DRQ
Fisher Imaging Corp.
Cardiovascular · 60d
Cleared Apr 27, 1987
PACEMAKER FUNCTION ANALYZER
K870909 · KRE
Paceart, Inc.
Cardiovascular · 53d
Cleared Apr 27, 1987
BLOOD VESSEL CONNECTOR
K871408
Quali-Med, Inc.
Cardiovascular · 19d
Cleared Apr 23, 1987
MODEL MICRO ST AMBULATORY ECG MONITOR
K870537 · DSH
Advanced Medical Products, Inc.
Cardiovascular · 73d
Cleared Apr 23, 1987
MODEL 192 PRINTER
K870538 · DSF
Advanced Medical Products, Inc.
Cardiovascular · 73d
Cleared Apr 23, 1987
PACE 10 NON-INVASIVE EXTERNAL PACEMAKER
K871176 · DRO
Medac, Inc.
Cardiovascular · 30d
Cleared Apr 22, 1987
EMT-102 CARDIAC MONITOR
K870049 · DXN
Evergreen Medical Technologies, Inc.
Cardiovascular · 106d
Cleared Apr 22, 1987
PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR
K870142 · DXY
Cardio-Pace Medical, Inc.
Cardiovascular · 99d