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
14665–14688 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 04, 1985
MEDTRONIC MODEL 5062
K853398 · DTB
Medtronic Vascular
Cardiovascular · 114d
Cleared Dec 04, 1985
LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08
K853517 · DTB
Intermedics, Inc.
Cardiovascular · 104d
Cleared Dec 04, 1985
POLYFLEX IMPLANTABLE PACING LEAD-476-07
K853521 · DTB
Intermedics, Inc.
Cardiovascular · 104d
Cleared Dec 04, 1985
EXPLORER
K853850 · DTB
Mansfield Scientific, Inc.
Cardiovascular · 79d
Cleared Dec 04, 1985
POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD
K854071 · DTB
Intermedics, Inc.
Cardiovascular · 61d
Cleared Dec 04, 1985
ARRHYTHMIA REVIEW STATION
K854136 · DXG
Marquette Electronics, Inc.
Cardiovascular · 55d
Cleared Dec 04, 1985
PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD
K854220 · DTB
Pacesetter Systems
Cardiovascular · 47d
Cleared Dec 04, 1985
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
K854261 · DTL
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 42d
Cleared Dec 04, 1985
KONTRON DEFIBRILLATOR 7501
K854307 · LDD
Kontron Instruments, Inc.
Cardiovascular · 40d
Cleared Dec 04, 1985
ACS INDEFLATOR (MODIFICATION)
K854310 · DXT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 41d
Cleared Dec 04, 1985
PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD
K854405 · DTB
Pacesetter Systems
Cardiovascular · 33d
Cleared Dec 03, 1985
SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM
K851365 · DXY
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 242d
Cleared Dec 03, 1985
L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION
K853099 · DTL
L.O.N. Research, Inc.
Cardiovascular · 133d
Cleared Dec 03, 1985
MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)
K853136 · MAV
E.A. Fischione Instrument Mfg.
Cardiovascular · 130d
Cleared Dec 03, 1985
CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN
K853383 · DYG
Webster Laboratories, Inc.
Cardiovascular · 113d
Cleared Dec 03, 1985
PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI
K853914 · DTB
Pacesetter Systems
Cardiovascular · 71d
Cleared Dec 03, 1985
COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS
K854132 · DXY
Cook Pacemaker Corp.
Cardiovascular · 54d
Cleared Dec 03, 1985
ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC
K854137 · DQY
Arrow Intl., Inc.
Cardiovascular · 54d
Cleared Dec 03, 1985
MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE
K854214 · DXY
Cordis Corp.
Cardiovascular · 47d
Cleared Nov 22, 1985
SILICONE OIL 350 CNETISTOKE
K854273 · KRD
Pacific Medical Industries
Cardiovascular · 63d
Cleared Nov 19, 1985
SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000
K851625 · DSF
Eaton Medical Group
Cardiovascular · 215d
Cleared Nov 19, 1985
OMNIGRAPH 4000(ELECTROCARDIOGRAPH)
K852652 · DRS
Telemed Div.
Cardiovascular · 151d
Cleared Nov 19, 1985
CARDIORATER CR7
K852910 · DRT
Cardiac Recorders, Ltd.
Cardiovascular · 133d
Cleared Nov 18, 1985
SUNBEAM HEALTH MONITOR MODEL NO. 7600
K852795 · DXN
Aanson Scale Co.
Cardiovascular · 140d