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
15049–15072 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 04, 1985
IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II
K851081 · DXY
Telectronics, Inc.
Cardiovascular · 17d
Cleared Apr 03, 1985
POLY FLEX IMPLANTABLE PACING LEAD
K802294 · DTB
Intermedics, Inc.
Cardiovascular · 1657d
Cleared Apr 03, 1985
MODEL 486-01 PACEMAKER LEAD
K813135 · DTB
Intermedics, Inc.
Cardiovascular · 1245d
Cleared Apr 03, 1985
MODEL 492-01 PACEMAKER LEAD
K813136 · DTB
Intermedics, Inc.
Cardiovascular · 1245d
Cleared Apr 03, 1985
INTERMEDICS POLYFLEX PACING LEAD #480-01
K820267 · DTB
Intermedics, Inc.
Cardiovascular · 1156d
Cleared Apr 03, 1985
PROGRAMMABLE PATIENT SIMULATOR
K844464 · DSI
Ramford Labs
Cardiovascular · 134d
Cleared Apr 03, 1985
VENOUS RETURN CATHETER SS-1
K845045 · DWF
Dlp, Inc.
Cardiovascular · 96d
Cleared Apr 03, 1985
PUL,MONARY ARTERY VENT CATHETER
K845046 · DWF
Dlp, Inc.
Cardiovascular · 96d
Cleared Apr 03, 1985
ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR
K850271 · DQO
Angiomedics, Inc.
Cardiovascular · 70d
Cleared Apr 01, 1985
PHYSIOLOGICAL MONITOR 2100
K844353 · DXN
Datascope Corp.
Cardiovascular · 143d
Cleared Apr 01, 1985
DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX
K844839 · DXN
Critikon Company, LLC
Cardiovascular · 110d
Cleared Apr 01, 1985
PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR
K850651 · DXY
Pacesetter Systems
Cardiovascular · 41d
Cleared Mar 29, 1985
NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER
K850487 · DSF
Novametrix Medical Systems, Inc.
Cardiovascular · 50d
Cleared Mar 28, 1985
MODEL 486-01 PACING LEAD
K844259 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 476-03 PACING LEAD
K844260 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 490-01 PACING LEAD
K844261 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 483-01 PACING LEAD
K844262 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 493-01 PACING LEAD
K844263 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 493-03 PACING LEAD
K844264 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 495-01 PACING LEAD
K844265 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 492-01 PACING LEAD
K844266 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 483-01 PACING LEAD
K844267 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 483-03 PACING LEAD
K844268 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 483-02 PACING LEAD
K844269 · DTB
Intermedics, Inc.
Cardiovascular · 143d