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
15073–15096 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 28, 1985
MODEL 480-01 PACING LEAD
K844270 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 479-01 PACING LEAD
K844271 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 28, 1985
MODEL 473-03 PACING LEAD
K844272 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Mar 27, 1985
PATHFINDER CARDIOVASCULAR CATHETER
K844555 · DQO
Argon Medical Corp.
Cardiovascular · 126d
Cleared Mar 27, 1985
KONTRON MINIMON 7132 PATIENT MONITOR
K844732 · DRT
Kontron Instruments, Inc.
Cardiovascular · 113d
Cleared Mar 27, 1985
KONTRON MINIMON 7131 PATIENT MONITOR
K844733 · DRT
Kontron Instruments, Inc.
Cardiovascular · 113d
Cleared Mar 27, 1985
CORDIS ENCOR PERVENOUS ATRIAL & VENTRICULAR LEADS
K844970 · DTB
Cordis Corp.
Cardiovascular · 93d
Cleared Mar 27, 1985
ELECATH OPEN TIP BIPOLAR PACING CATHETER
K850324 · LDF
Electro-Catheter Corp.
Cardiovascular · 58d
Cleared Mar 27, 1985
BLOOD OXYGENATOR MODEL NO. MAX-5
K850630 · DTZ
American Bentley
Cardiovascular · 36d
Cleared Mar 25, 1985
UTAH DISPOSABLE PRESSURE TRANSDUCER
K841788 · DRS
Utah Medical Products, Inc.
Cardiovascular · 329d
Cleared Mar 25, 1985
PRESSURE MONITORING KIT
K842352 · DRS
Utah Medical Products, Inc.
Cardiovascular · 283d
Cleared Mar 21, 1985
CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER
K850384 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 48d
Cleared Mar 12, 1985
SCANHEADS-ACCESS 10PV, BIOSTATIC
K843620 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 179d
Cleared Mar 12, 1985
SCANHEADS ACCESS 10 10PV B10
K843953 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 154d
Cleared Mar 07, 1985
AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH
K844901 · DTZ
American Bentley
Cardiovascular · 80d
Cleared Mar 06, 1985
CARDIO ANALYZER MODEL 380
K844104 · LOS
Birtcher Corp.
Cardiovascular · 134d
Cleared Mar 06, 1985
ELECATH CARDIAC OUTPUT COMPUTER
K844682 · DXG
Electro-Catheter Corp.
Cardiovascular · 96d
Cleared Mar 06, 1985
PEEL-AWAY INTRODUCER SET
K844693 · DYB
Quinton, Inc.
Cardiovascular · 93d
Cleared Mar 06, 1985
MEDTRONIC 5061 ENDOCARDIAL PACING LEAD
K844974 · DTD
Medtronic Vascular
Cardiovascular · 72d
Cleared Mar 06, 1985
PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR
K850576 · DTD
Pacesetter Systems
Cardiovascular · 21d
Cleared Mar 06, 1985
PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY &
K850596 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 19d
Cleared Mar 05, 1985
ACCESS C
K843911 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 153d
Cleared Mar 05, 1985
NEBULIZER TREATMENT KIT
K850320
Dhd Medical Products Div. Diemolding...
Cardiovascular · 36d
Cleared Mar 01, 1985
PHONOANGIOGRAPHIC SPECTRAL ANALYZER
K840169 · DPW
Biotronics Instruments
Cardiovascular · 410d