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
16345–16368 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 12, 1982
ELECTROENCEPHALOGRAPH ECG-6151
K820067 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 32d
Cleared Feb 12, 1982
SYSTEM V.HEART RATE/RESPIR. RATE MONIT.
K820114 · DRT
Narco Air-Shields
Cardiovascular · 28d
Cleared Feb 12, 1982
LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD.
K820121 · DTB
Telectronics, Inc.
Cardiovascular · 25d
Cleared Feb 12, 1982
BARD CARDIOPULMONARY MONITORING LINES
K820186 · DRS
C.R. Bard, Inc.
Cardiovascular · 21d
Cleared Feb 12, 1982
DISPOS. MONITORING SYS/LI ET AL
K820201 · DRS
Linton Biomed Corp.
Cardiovascular · 17d
Cleared Feb 12, 1982
CONTINUOUS FLUSH DEVICE/FDI
K820202 · DRS
Linton Biomed Corp.
Cardiovascular · 17d
Cleared Feb 12, 1982
SWAN-GANZ VIP-CATHETER
K820222 · DYG
American Edwards Laboratories
Cardiovascular · 16d
Cleared Feb 12, 1982
NORTON FLOW DIRECTED THERMODILUTION CATH
K820229 · DYG
Norton Performance Plastics Corp.
Cardiovascular · 16d
Cleared Feb 12, 1982
TELESCAN T-30
K820276 · DXH
Telescan Medical Systems
Cardiovascular · 10d
Cleared Feb 04, 1982
CAPILLARY PERFUSION MONITOR #LD5000
K812005 · DPW
Nuclear Pacific, Inc.
Cardiovascular · 205d
Cleared Feb 04, 1982
PERMANENT ENDOCARD. UNIPOLAR TINED LEAD
K812905 · DTB
Diag Corp.
Cardiovascular · 108d
Cleared Jan 29, 1982
NIHON KOHDEN ELECTROCARDIOGRAPH
K813266 · DRS
Nihon Kohden America, Inc.
Cardiovascular · 70d
Cleared Jan 29, 1982
DIGITAL BLOOD PRESSURE UNIT
K813385 · DXN
Conphar, Inc.
Cardiovascular · 58d
Cleared Jan 29, 1982
PRESSURE INDICATOR-REGULATOR
K813577 · DQO
Advanced Catheter Systems
Cardiovascular · 37d
Cleared Jan 29, 1982
HOLTER PERFORMER
K813602 · DSH
Applied Cardiac Systems
Cardiovascular · 32d
Cleared Jan 29, 1982
CORONARY INFUSION KIT
K820001 · DQO
Mallinckrodt Critical Care
Cardiovascular · 25d
Cleared Jan 29, 1982
CARDIOVASCULAR DEVICES
K820045 · DTM
Bentley Laboratories, Inc.
Cardiovascular · 22d
Cleared Jan 29, 1982
ANESTHESIOLOGY DEVICES
K820046 · DRS
Bentley Laboratories, Inc.
Cardiovascular · 22d
Cleared Jan 29, 1982
SUBCLAVIAN JUGULAR CATHETER SET
K820102 · DQR
Luther Medical Products, Inc.
Cardiovascular · 14d
Cleared Jan 28, 1982
INTERSEPT CARDIOTOMY RESERVOIR/FILTER
K813205 · DTB
Extracorporeal Medical Specialities,...
Cardiovascular · 76d
Cleared Jan 26, 1982
LINQUAL-ORAL TRAINING SPLINT
K813603
Charles F. Samelson, M.D.
Cardiovascular · 29d
Cleared Jan 22, 1982
BRADYCARDIA ALARM
K813174 · DRT
Douglas Scientific Products
Cardiovascular · 77d
Cleared Jan 22, 1982
REGU-VAC OXYGENATING SUCTION CATHETER
K813220
Bd Becton Dickinson Vacutainer...
Cardiovascular · 74d
Cleared Jan 22, 1982
CONPHAR PALM ANEROID SPHYGMOMANOMETER
K813302 · DXQ
Conphar, Inc.
Cardiovascular · 60d