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
14713–14736 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 05, 1985
INFUSION CATHETER
K853997 · DQY
Target Therapeutics
Cardiovascular · 36d
Cleared Nov 05, 1985
GUIDE WIRE
K853999 · DQX
Target Therapeutics
Cardiovascular · 36d
Cleared Nov 05, 1985
INFUSION CATHETER W/SIDE HOLES
K854000 · DQY
Target Therapeutics
Cardiovascular · 36d
Cleared Nov 01, 1985
PERCUTANEOUS GREENFIELD VENA CAVA FILTER SYSTEM
K852097 · DTK
Medi-Tech, Inc.
Cardiovascular · 170d
Cleared Nov 01, 1985
FAP-CATH
K852456 · DQO
Research Medical, Inc.
Cardiovascular · 144d
Cleared Nov 01, 1985
MEDTRONICS MODELS 8320/8322/8329
K852688 · DXY
Medtronic Vascular
Cardiovascular · 129d
Cleared Nov 01, 1985
CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK
K852748 · DXY
Cordis Corp.
Cardiovascular · 127d
Cleared Nov 01, 1985
DUROMEDICS CARDIAC VALVE SIZER SET
K853313 · DTI
Hemex Scientific, Inc.
Cardiovascular · 86d
Cleared Nov 01, 1985
BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS
K854143 · DXY
Telectronics, Inc.
Cardiovascular · 21d
Cleared Oct 31, 1985
IRREGULAR CURVE TRACING REVISITION & DOPPLER
K853769 · DXK
Hewlett-Packard Co.
Cardiovascular · 52d
Cleared Oct 29, 1985
MILLAR MIKRO-TIP DOPPLER CATHETER
K853138 · JOP
Millar Instruments, Inc.
Cardiovascular · 95d
Cleared Oct 24, 1985
DIAGNOSTIC ECG DISPOSABLE ELECTRODE
K851522 · DRX
Sentry Medical Products, Inc.
Cardiovascular · 192d
Cleared Oct 24, 1985
LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03
K853519 · DTB
Intermedics, Inc.
Cardiovascular · 63d
Cleared Oct 23, 1985
MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417
K850165 · JOP
Hoffrel Instruments, Inc.
Cardiovascular · 280d
Cleared Oct 23, 1985
COMPANION 2800 VOLUME VENTILATOR
K851366
Puritan Bennett Corp.
Cardiovascular · 201d
Cleared Oct 23, 1985
750 SD ULTRASOUND SCANNER(MODIFICATION)
K851901 · DXK
Ultrasonix, Inc.
Cardiovascular · 176d
Cleared Oct 23, 1985
COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI
K853590 · DXY
Cook Pacemaker Corp.
Cardiovascular · 56d
Cleared Oct 23, 1985
COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER
K853651 · DXY
Cook Pacemaker Corp.
Cardiovascular · 50d
Cleared Oct 23, 1985
VEDLAR VENTILATOR (MODIFICATION)
K854026
Hamilton Medical, Inc.
Cardiovascular · 58d
Cleared Oct 23, 1985
MANUAL VENTILATION ACCESSORY
K854036
Siemens Elema AB
Cardiovascular · 57d
Cleared Oct 22, 1985
#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER
K852971 · DXH
Medtronic Vascular
Cardiovascular · 99d
Cleared Oct 21, 1985
SENSOR TAPE CAT. NO. ST-45
K852407 · DTW
American Omni Medical, Inc.
Cardiovascular · 137d
Cleared Oct 21, 1985
ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO
K853746 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 42d
Cleared Oct 18, 1985
REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE
K853860 · DQY
Quinton, Inc.
Cardiovascular · 31d