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
14881–14904 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 11, 1985
IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE
K851461 · DTB
Telectronics, Inc.
Cardiovascular · 91d
Cleared Jul 11, 1985
NAMAN POTTS COURNAND NEEDLE
K851832 · DWS
Manan Manufacturing Co., Inc.
Cardiovascular · 76d
Cleared Jul 11, 1985
MANAN SELDINGER NEEDLE
K851833 · DWS
Manan Manufacturing Co., Inc.
Cardiovascular · 76d
Cleared Jul 11, 1985
MANAN GWI GUIDE WIRE INTRODUCER
K851834 · DWS
Manan Manufacturing Co., Inc.
Cardiovascular · 76d
Cleared Jul 11, 1985
MEDTRONIC MODEL 5867-1A
K852236 · KFJ
Medtronic Vascular
Cardiovascular · 50d
Cleared Jul 08, 1985
BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18)
K851415 · DSB
Medi-Sport Testing, Inc.
Cardiovascular · 90d
Cleared Jul 01, 1985
OHMEDA CPU MONITOR
K852504
Ohmeda Medical
Cardiovascular · 19d
Cleared Jun 28, 1985
CARDIAC EVENT RECORDER
K843533 · DRT
Cryo2 Corp.
Cardiovascular · 294d
Cleared Jun 27, 1985
RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO
K851628 · DXJ
Eaton Medical Group
Cardiovascular · 70d
Cleared Jun 26, 1985
MODEL 9300 TREND ANALYZING BIO-MONITOR SYS
K844252 · DXN
Medtronic Vascular
Cardiovascular · 236d
Cleared Jun 26, 1985
GUIDE, WIRE, ANGIOGRAPHIC
K850827 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 121d
Cleared Jun 26, 1985
WIRE, GUIDE - MODIFICATION
K850828 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 121d
Cleared Jun 26, 1985
WIRE, GUIDE, CATHETER
K850829 · DQY
Lake Region Mfg., Inc.
Cardiovascular · 121d
Cleared Jun 26, 1985
CARDIOSTAT 3 RECORDER
K851044 · DPS
Siemens Elema AB
Cardiovascular · 104d
Cleared Jun 26, 1985
SIRECUST 420 PATIENT DIALOG MONITOR
K851400 · DXJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 78d
Cleared Jun 26, 1985
SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE
K851626 · DSF
Eaton Medical Group
Cardiovascular · 69d
Cleared Jun 26, 1985
CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL
K851633 · DPS
Eaton Medical Group
Cardiovascular · 69d
Cleared Jun 25, 1985
VENOUS RESERVOIR BAG BMR-1600
K851376 · DTN
American Bentley
Cardiovascular · 78d
Cleared Jun 25, 1985
VENUOS RESERVOIR BAG BMR-1900
K851401 · DTN
American Bentley
Cardiovascular · 77d
Cleared Jun 24, 1985
LASERFLO BLOOD PERFUSION MONITOR 403
K851057 · DPW
Tsi, Inc.
Cardiovascular · 102d
Cleared Jun 24, 1985
MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR
K851152 · DWS
Cryomedics, Inc.
Cardiovascular · 95d
Cleared Jun 21, 1985
FUKUDA DENSHI EH-11
K834059 · DXG
Fukuda Denshi USA, Inc.
Cardiovascular · 574d
Cleared Jun 21, 1985
CARDIOVASCULAR CUSTOM SURGICAL KIT
K844593 · DYB
Xanmed Corp.
Cardiovascular · 207d
Cleared Jun 21, 1985
PERCUTANEOUS ANGIOGRAPHIC NEEDLES
K845037 · DYB
Mallinckrodt Critical Care
Cardiovascular · 176d