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
15649–15672 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 16, 1983
BATTERY-OPERATED ELECTROCARDIOGRAPH
K832421 · DPS
Somatronix Research Corp.
Cardiovascular · 147d
Cleared Dec 16, 1983
MAGNATRODE CARDIAC MONITORING ELECTRODE
K832516 · DRX
R2 Corp.
Cardiovascular · 141d
Cleared Dec 16, 1983
TUBING CONNECTORS EC-2XXX SERIES
K833322 · DTL
Gish Biomedical, Inc.
Cardiovascular · 81d
Cleared Dec 16, 1983
WILLIAM HARVEY H-71-5-F CARDIOTOMY
K833479 · DTN
C.R. Bard, Inc.
Cardiovascular · 70d
Cleared Dec 16, 1983
PACEMAKER SYS ANALYZER #384
K833647 · KRE
Pacesetter Systems
Cardiovascular · 60d
Cleared Dec 16, 1983
8 FRENCH DILATOR 15CM, W/LUER LOCK
K833965 · DRE
Quinton, Inc.
Cardiovascular · 30d
Cleared Dec 16, 1983
IMPLANTABLE PULSE GENERATOR
K834096 · DXY
Intermedics, Inc.
Cardiovascular · 18d
Cleared Dec 13, 1983
MORTARA INSTRUMENT #101
K832050 · DPS
Mortara Instrument, Inc.
Cardiovascular · 172d
Cleared Dec 06, 1983
DIF-STET
K832882 · DQD
Intersect Systems, Inc.
Cardiovascular · 102d
Cleared Dec 06, 1983
MINI-PECG
K832883 · DPS
Intersect Systems, Inc.
Cardiovascular · 102d
Cleared Dec 01, 1983
PATIENT MONITOR CM 135
K831164 · DRT
Honeywell, Inc.
Cardiovascular · 234d
Cleared Dec 01, 1983
BIOSENSOR ASC SYSTEM
K831676 · DSI
Biosensor Corp.
Cardiovascular · 192d
Cleared Dec 01, 1983
G-2000
K832227 · DPS
Eaton Medical Group
Cardiovascular · 146d
Cleared Dec 01, 1983
PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH
K832374 · JOM
Sonicaid, Inc.
Cardiovascular · 136d
Cleared Dec 01, 1983
SHILEY M2000 MEMBRANE OXYGENATOR
K833253 · DTZ
Shiley, Inc.
Cardiovascular · 72d
Cleared Dec 01, 1983
NAMIC CONTINUOUS FLUSH DEVICE
K833271 · DRS
North American Instrument Corp.
Cardiovascular · 71d
Cleared Dec 01, 1983
OPTIMA MDT PULSE GENERATOR W/TELEMETRY
K833798 · DXY
Telectronics, Inc.
Cardiovascular · 31d
Cleared Dec 01, 1983
HOLTER PERFORMER FEATHER WEIGHT/CASS
K833823 · DSH
Applied Cardiac Systems
Cardiovascular · 29d
Cleared Dec 01, 1983
ENDOCARDIAL SCREW-IN LEAD 859 & 861
K833824 · DTB
Pacesetter Systems
Cardiovascular · 31d
Cleared Nov 28, 1983
PROTECTIVE SLEEVE
K832380 · DYG
Vertex Medical Corp.
Cardiovascular · 132d
Cleared Nov 28, 1983
TUBING FOR CARDIOPULMONARY BYPASS
K833112 · DWF
Cardio Med Supplies, Inc.
Cardiovascular · 104d
Cleared Nov 28, 1983
ELECTROCARDIOCORDER RECORDER 453
K833661 · DSH
Del Mar Avionics
Cardiovascular · 41d
Cleared Nov 16, 1983
SERVOMED BASIC BEDSIDE UNIT SMVIII W
K831781 · DXJ
Litton Medical Electronics
Cardiovascular · 167d
Cleared Nov 16, 1983
SERVOMED BASIC BEDSIDE UNIT SMV 107
K831782 · DXJ
Litton Medical Electronics
Cardiovascular · 167d