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
14113–14136 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 06, 1987
CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.
K863917 · DYB
Cardio-Vascular Innovations, Inc.
Cardiovascular · 90d
Cleared Jan 06, 1987
PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)
K864062 · DXE
Ideas For Medicine, Inc.
Cardiovascular · 78d
Cleared Jan 06, 1987
PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290
K864153 · DTB
Pace Medical
Cardiovascular · 75d
Cleared Jan 06, 1987
SHEAR FORCE GAUGE
K864330 · DXE
American Edwards Laboratories
Cardiovascular · 63d
Cleared Jan 06, 1987
MODIFIED PEEL-AWAY INTRODUCER SET LINE
K864352 · DYB
Quinton, Inc.
Cardiovascular · 63d
Cleared Jan 06, 1987
MODIFIED RLV-2100 B
K864503 · DWD
American Omni Medical, Inc.
Cardiovascular · 53d
Cleared Jan 06, 1987
CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD
K864601 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 43d
Cleared Jan 06, 1987
MODIFIED ESCHMANN DILATATION CATHETER
K864637
Eschmann Bros. & Walsh , Ltd.
Cardiovascular · 48d
Cleared Jan 06, 1987
ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD
K864640 · DTB
Cordis Corp.
Cardiovascular · 41d
Cleared Jan 06, 1987
SALT CREEK P.I. TRAY
K864682
Salt Creek Medical Technologies
Cardiovascular · 35d
Cleared Jan 06, 1987
MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP
K864738 · DTB
Intermedics, Inc.
Cardiovascular · 33d
Cleared Jan 06, 1987
MODEL 5866-24 PACEMAKER LEAD ADAPTOR
K864856 · DTB
Medtronic Vascular
Cardiovascular · 26d
Cleared Jan 05, 1987
1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER
K861205 · DSB
Valhalla Scientific
Cardiovascular · 280d
Cleared Jan 02, 1987
MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE
K862459 · DXY
Medtronic Vascular
Cardiovascular · 186d
Cleared Jan 02, 1987
VEIN VALVE CUTTER
K862724 · DQY
American Edwards Laboratories
Cardiovascular · 169d
Cleared Jan 02, 1987
2200I PHYSIOLOGICAL MONITOR
K863308 · DXG
Datascope Corp.
Cardiovascular · 130d
Cleared Jan 02, 1987
EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER
K864007 · DXE
Uresil Corp.
Cardiovascular · 79d
Cleared Jan 02, 1987
BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600
K864235 · DTZ
C.R. Bard, Inc.
Cardiovascular · 66d
Cleared Jan 02, 1987
ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING
K864262 · DTM
Johnson & Johnson Professionals, Inc.
Cardiovascular · 65d
Cleared Dec 22, 1986
NBP 488, TPR 488
K861856 · DXN
Siemens Medical Solutions USA, Inc.
Cardiovascular · 222d
Cleared Dec 22, 1986
HEALTHPHONE(TM)
K862668 · DXH
Carelink
Cardiovascular · 161d
Cleared Dec 22, 1986
M700 STRESS MONITOR
K863466 · DRT
Kone Instruments, Inc.
Cardiovascular · 105d
Cleared Dec 22, 1986
NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20
K863494 · DRT
Advantage Medical Systems, Inc.
Cardiovascular · 104d
Cleared Dec 22, 1986
RNET SYSTEM, IV RECEIVING TERMINAL, TRANSMITTER
K863716
Futurecare Systems, Inc.
Cardiovascular · 90d