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
16993–17016 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 08, 1980
SERIES 602 CKG RECORDER (MODIFIED)
K801485 · DSF
Cardio Kinetics, Inc.
Cardiovascular · 14d
Cleared Jul 08, 1980
ABBY II PATIENT MONITOR OR VITAL SIGNS M
K801515 · DRT
Abbott Medical Electronics Co.
Cardiovascular · 8d
Cleared Jun 30, 1980
PERMANENT & TEMP. PACEMAKER ELECTRODE
K800795 · DTB
Daig Corp.
Cardiovascular · 82d
Cleared Jun 30, 1980
PROGRAMMABLE BIPOLAR CARDIAC GENERATOR
K800837 · DXY
Arco Medical Products Co.
Cardiovascular · 76d
Cleared Jun 30, 1980
GE LEAD ADAPTER, MODEL 345-01
K801040 · DTD
Intermedics, Inc.
Cardiovascular · 59d
Cleared Jun 30, 1980
MICROTHIN-P1 (MOD. 0622)
K801121 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 49d
Cleared Jun 30, 1980
MICROTHIN-D1 (MOD. 0620)
K801122 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 49d
Cleared Jun 30, 1980
UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN.
K801241 · DXY
Arco Medical Products Co.
Cardiovascular · 34d
Cleared Jun 30, 1980
PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE
K801321 · DQO
Graphic Controls Corp.
Cardiovascular · 25d
Cleared Jun 30, 1980
MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS
K801322 · DQO
Graphic Controls Corp.
Cardiovascular · 25d
Cleared Jun 30, 1980
DISPOSABLE SUMP SETS
K801392 · DWF
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
AIR ASPIRATOR NEEDLE
K801393 · DWS
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
CARDIOPULMONARY BYPASS PUMP TUBING
K801394 · DWE
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
VASCULAR CLAMP
K801395 · DXC
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
SAPHENOUS VEIN CANNULAE
K801396 · DWF
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
VENA CAVA CANNULAE
K801397 · DWF
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
AORTIC AND FEMORAL PERFUSION CANNULAE
K801398 · DWF
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
CORONARY PERFUSION CONNECTOR PLUG
K801399 · DTL
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
DISPOSABLE SUCKER SYSTEM
K801400 · DTS
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
CARDIOPULMONARY BYPASS TUBING
K801401 · DWF
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
QUICKIE PRIME CARDIOP. BYPASS PERF. INTR
K801402 · DTL
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
DISPOSABLE PERFUSION SET
K801403 · DWF
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
DISPOSABLE PARALLEL Y CONNECTORS
K801404 · DTL
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
DISPOSABLE PERFUSION CONNECTORS
K801405 · DTL
Texas Medical Products, Inc.
Cardiovascular · 17d