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
16873–16896 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 12, 1980
EXTERNAL JUGULAR CVP CATHERIZATION KIT
K802576 · DRX
Willson
Cardiovascular · 23d
Cleared Nov 12, 1980
AMP PORTABLE PATIENT PRESSURE MONITOR
K802600 · DSK
American Medical Products, Inc.
Cardiovascular · 22d
Cleared Nov 12, 1980
L-3 PURGE LINE
K802602 · DTM
Delta Medical Industries
Cardiovascular · 22d
Cleared Oct 31, 1980
COMPUPACE, 524-01 PACER SYSTEM COMPUTER
K801055 · DTE
Intermedics, Inc.
Cardiovascular · 178d
Cleared Oct 31, 1980
PACEPATH MODEL 810
K801416 · DTB
Pacesetter Systems
Cardiovascular · 137d
Cleared Oct 31, 1980
WISCONSIN HEART RATE MONITOR
K802182 · DRT
Lunar Radiation Corp.
Cardiovascular · 52d
Cleared Oct 31, 1980
POLYFLEX IMPLANTABLE PACING LEAD
K802293 · DTB
Intermedics, Inc.
Cardiovascular · 42d
Cleared Oct 31, 1980
PACEMAKER LEAD ADAPTOR MODEL 431
K802407 · DTD
Pacesetter Systems
Cardiovascular · 28d
Cleared Oct 31, 1980
MICROTHIN-DI BIPOLAR PULSE GENERATOR
K802409 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 28d
Cleared Oct 31, 1980
MICROTHIN-PI BIPOLAR PULSE GENERATOR
K802410 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 28d
Cleared Oct 31, 1980
7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH
K802481 · DYG
Waters Assoc., Inc.
Cardiovascular · 24d
Cleared Oct 31, 1980
STERI-SLEEVE
K802629 · DQO
Cordis Corp.
Cardiovascular · 8d
Cleared Oct 28, 1980
L-15T ENDOCARDIAL PACING ELECTRODE
K802689
Coratomic, Inc.
Cardiovascular
Cleared Oct 23, 1980
PACEPATH MODEL 819
K801417 · DTB
Pacesetter Systems
Cardiovascular · 129d
Cleared Oct 23, 1980
LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM
K801455 · DTB
Pacesetter Systems
Cardiovascular · 121d
Cleared Oct 23, 1980
IMPLANTABLE ENDOCARDIAL POROUS TIP ELEC.
K801792 · DTB
Telectronics, Inc.
Cardiovascular · 86d
Cleared Oct 23, 1980
UNIVERSAL TEMP. PACING ELECT. #080-10000
K801800 · LDF
Medical Testing System, Inc.
Cardiovascular · 86d
Cleared Oct 23, 1980
MULTICHANNEL TELEMETRY SYSTEM
K801944 · DRG
Burdick Corp.
Cardiovascular · 70d
Cleared Oct 23, 1980
EXTERNAL, TEMP. PORTABLE CARDIAC GENER
K801953 · DTE
Telectronics, Inc.
Cardiovascular · 66d
Cleared Oct 23, 1980
UNIPOLAR TO BIPOLAR PULSE GEN. ADAPTER
K802077 · DTD
Cardiac Pacemakers, Inc.
Cardiovascular · 56d
Cleared Oct 23, 1980
MODEL 633A THREE CHANNEL STRESS TEST
K802190 · DPS
Quinton, Inc.
Cardiovascular · 43d
Cleared Oct 23, 1980
SD-700 BLOOD PRESSURE MONITOR
K802201 · DXN
Industrial & Biomedical Sensors Corp.
Cardiovascular · 42d
Cleared Oct 23, 1980
SD-800 BLOOD PRESSURE MONITOR
K802202 · DXN
Industrial & Biomedical Sensors Corp.
Cardiovascular · 42d
Cleared Oct 23, 1980
SD-900 OSCILLOMETRIC BP MONITOR
K802218 · DXN
Industrial & Biomedical Sensors Corp.
Cardiovascular · 41d