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
14785–14808 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 16, 1985
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD
K852513 · LDF
C.R. Bard, Inc.
Cardiovascular · 96d
Cleared Sep 16, 1985
HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE
K852797 · LDF
Mansfield Scientific, Inc.
Cardiovascular · 80d
Cleared Sep 16, 1985
2006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR)
K852799 · LDD
Cardiac Recorders, Ltd.
Cardiovascular · 77d
Cleared Sep 16, 1985
CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO)
K852808 · LDD
Cardiac Recorders, Ltd.
Cardiovascular · 76d
Cleared Sep 16, 1985
IMPLANTABLE ELECTRODE LEAD, MODEL 030-400
K852972 · DTB
Telectronics, Inc.
Cardiovascular · 63d
Cleared Sep 15, 1985
TEMPORARY PACEMAKER GROUND WIRE
K852119 · DTB
Scholten Surgical Instruments, Inc.
Cardiovascular · 123d
Cleared Sep 13, 1985
NEOS - M ABP
K853058 · DXY
Biotronik Sales, Inc.
Cardiovascular · 56d
Cleared Sep 12, 1985
NORELCO ELECTRONIC DIGITAL BP METER HC3501
K852128 · DXN
Philips Park
Cardiovascular · 120d
Cleared Sep 12, 1985
MODEL 78560A CENTRAL STATION PATIENT INFO SYS
K852514 · DSI
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Sep 12, 1985
EXTERNAL PACEMAKER TELECTRONICS TE200
K852746 · JOQ
Seamed Corp.
Cardiovascular · 77d
Cleared Sep 12, 1985
TRIOS - M
K853057 · DXY
Biotronik Sales, Inc.
Cardiovascular · 55d
Cleared Sep 12, 1985
IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW
K853206 · DXY
Telectronics, Inc.
Cardiovascular · 43d
Cleared Sep 11, 1985
VSM-5
K852322 · DPS
Physio-Control Corp.
Cardiovascular · 104d
Cleared Sep 09, 1985
BENTLEY-TRANTEC DISPOS. DOMES D-260-
K841811 · DRS
American Bentley
Cardiovascular · 496d
Cleared Sep 09, 1985
COPAL DIGITAL SPHYGMOMANOMETER UA-560
K851223 · DXN
Takeda Medical, Inc.
Cardiovascular · 167d
Cleared Sep 09, 1985
REMOTE CONTROL MODULE
K851643 · DPS
Circadian, Inc.
Cardiovascular · 143d
Cleared Sep 06, 1985
CPR PROMPT
K853428
Hutchins Tool & Engineering Co., Inc.
Cardiovascular · 22d
Cleared Aug 29, 1985
BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD
K844814 · DTD
Intermedics, Inc.
Cardiovascular · 261d
Cleared Aug 29, 1985
MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN
K850968 · DTD
Medtronic Vascular
Cardiovascular · 174d
Cleared Aug 29, 1985
DEFI 502
K851485 · LDD
Robert Bosch Corp.
Cardiovascular · 136d
Cleared Aug 29, 1985
ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860
K851731 · DTB
Ela Medical, Inc.
Cardiovascular · 126d
Cleared Aug 29, 1985
NUMED TEMP. STYLET PACING PAROBE 1318694
K851845 · LDF
NuMED, Inc.
Cardiovascular · 125d
Cleared Aug 29, 1985
PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET)
K852880 · DYB
Argon Medical Corp.
Cardiovascular · 51d
Cleared Aug 26, 1985
TRIPLE LUMEN RIGHT ATRIAL CATHETER
K852815 · DQY
Quinton, Inc.
Cardiovascular · 55d