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
15025–15048 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 10, 1985
ELECATH TORKFLOAT PACING PROBE
K850065 · DTB
Electro-Catheter Corp.
Cardiovascular · 92d
Cleared Apr 10, 1985
SCIMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILAT
K850075 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 91d
Cleared Apr 10, 1985
COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER
K850139 · KRJ
Rapid Diagnostic Laboratories, Inc.
Cardiovascular · 86d
Cleared Apr 10, 1985
CARDIAC SECTOR PROBE 3.5. MHZ
K850145 · JOP
Siemens Medical Solutions USA, Inc.
Cardiovascular · 86d
Cleared Apr 10, 1985
CARDIAC SECTOR PROBE 5.0 MHZ
K850216 · JOP
Siemens Medical Solutions USA, Inc.
Cardiovascular · 78d
Cleared Apr 10, 1985
CORONARY INFUSION CATHETER W/SIDEHOLES
K850353 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 71d
Cleared Apr 10, 1985
OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR
K850622 · LDF
Oscor Medical Corp.
Cardiovascular · 50d
Cleared Apr 10, 1985
PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD
K850652 · DTD
Pacesetter Systems
Cardiovascular · 50d
Cleared Apr 10, 1985
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER
K850760 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 44d
Cleared Apr 10, 1985
PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID
K850820 · DYB
Universal Medical Instrument Corp.
Cardiovascular · 41d
Cleared Apr 10, 1985
FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES
K850897 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 37d
Cleared Apr 10, 1985
PORTABLE DEFIBRILLATOR/MONITOR ED 425
K851092 · LDD
Honeywell, Inc.
Cardiovascular · 22d
Cleared Apr 10, 1985
IMPLANTABLE ELECTRODE LEAD 030-272 USING POLYURETH
K851294 · DTB
Telectronics, Inc.
Cardiovascular · 9d
Cleared Apr 10, 1985
IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH
K851295 · DTB
Telectronics, Inc.
Cardiovascular · 9d
Cleared Apr 10, 1985
IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET
K851297 · DTB
Telectronics, Inc.
Cardiovascular · 9d
Cleared Apr 09, 1985
CARDIO-NEC MODEL 365
K844101 · DPS
Birtcher Corp.
Cardiovascular · 168d
Cleared Apr 09, 1985
IAI PROGRAM-COMPUTER PROGRAM
K844997 · DXG
Intl. Acoustics, Inc.
Cardiovascular · 104d
Cleared Apr 09, 1985
PRN ECG ELECTRODE
K850130 · DRX
Consolidated Medical Equipment, Inc.
Cardiovascular · 85d
Cleared Apr 09, 1985
DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC
K850132 · DRX
Consolidated Medical Equipment, Inc.
Cardiovascular · 85d
Cleared Apr 09, 1985
RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE
K850365 · DSF
Eaton Medical Group
Cardiovascular · 69d
Cleared Apr 09, 1985
MODEL 78231D CARDIAC OUTPUT MODULE
K850568 · DXG
Hewlett-Packard Co.
Cardiovascular · 56d
Cleared Apr 04, 1985
KONTRON MINIMON 7134 PATIENT MONITOR
K844215 · DRT
Kontron Instruments, Inc.
Cardiovascular · 155d
Cleared Apr 04, 1985
ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS.
K844988 · DXQ
Ethox Corp.
Cardiovascular · 99d
Cleared Apr 04, 1985
QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR
K850252 · DXY
Telectronics, Inc.
Cardiovascular · 72d