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
14689–14712 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 18, 1985
OMRON DIGITAL BP MONITOR HEM-700C
K853260 · DXN
Omron Tateisi Electronics Co.
Cardiovascular · 108d
Cleared Nov 14, 1985
EBM-500
K840574 · DXN
Bosch Hearing Instruments, Inc.
Cardiovascular · 645d
Cleared Nov 14, 1985
LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR
K851662 · DPS
Logos Medical Co., Ltd.
Cardiovascular · 205d
Cleared Nov 14, 1985
CR5 CARDIAC MONITOR
K852887 · DRT
Cardiac Recorders, Ltd.
Cardiovascular · 128d
Cleared Nov 14, 1985
PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM
K852968 · DSI
Personal Computers For Medicine, Inc.
Cardiovascular · 122d
Cleared Nov 14, 1985
DIGITAL SPHYGMOMANOMETER MODEL 7620
K853158 · DXN
Takeda Medical, Inc.
Cardiovascular · 107d
Cleared Nov 14, 1985
FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR
K853352 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 94d
Cleared Nov 14, 1985
SHILEY 3L CARDIOTOMY RESERVOIR
K853503 · DTP
Shiley, Inc.
Cardiovascular · 85d
Cleared Nov 14, 1985
SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM
K853516 · DTR
3M Health Care, Sarns
Cardiovascular · 84d
Cleared Nov 14, 1985
PRESSURE SENSING SYRINGE 65000
K853586 · DTL
Dlp, Inc.
Cardiovascular · 80d
Cleared Nov 08, 1985
CARDIO METRICS INVASIVE PRESSURE MONIT
K841960 · DRS
Sterile Design, Inc.
Cardiovascular · 543d
Cleared Nov 08, 1985
KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR
K851627 · DRW
Eaton Medical Group
Cardiovascular · 204d
Cleared Nov 08, 1985
PCX-100 PATIENT INPUT LEADWIRE
K851632 · DRW
Eaton Medical Group
Cardiovascular · 204d
Cleared Nov 08, 1985
SUPRIMA MODEL 254-22
K852339 · DXY
Intermedics, Inc.
Cardiovascular · 158d
Cleared Nov 08, 1985
SUPRIMA MODEL 254-24
K852340 · DXY
Intermedics, Inc.
Cardiovascular · 158d
Cleared Nov 06, 1985
LAP-CATH
K852197 · DQO
Research Medical, Inc.
Cardiovascular · 170d
Cleared Nov 06, 1985
NOVAMETRIX PULSE OXIMETER, MODEL 500
K853124 · JOM
Novametrix Medical Systems, Inc.
Cardiovascular · 104d
Cleared Nov 06, 1985
MVM 4000 HOLTER IV RECORDER
K853985 · DSH
Mountain View Medical
Cardiovascular · 40d
Cleared Nov 06, 1985
GUIDING CATHETER
K853998 · DQY
Target Therapeutics
Cardiovascular · 37d
Cleared Nov 05, 1985
EMERGIPACE - EXTERNAL PACEMAKER
K850812 · DRO
Life Science Instrumentation, Inc.
Cardiovascular · 250d
Cleared Nov 05, 1985
7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS
K852791 · DQY
Cardio-Vascular Innovations, Inc.
Cardiovascular · 127d
Cleared Nov 05, 1985
CR 280/45, CR281/4 DEFIBRILLATOR
K852905 · LDD
Cardiac Recorders, Ltd.
Cardiovascular · 119d
Cleared Nov 05, 1985
COMPAS 1
K853209 · DSI
Cardiac Care Units, Inc.
Cardiovascular · 97d
Cleared Nov 05, 1985
LIFELINE ENDOCARDIAL BIPOLAR LEAD 476-06
K853518 · DTB
Intermedics, Inc.
Cardiovascular · 75d