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
16177–16200 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 06, 1982
CAPIOX CR-CARDIOTOMY RESERVOIR
K821538 · DTP
Terumo Medical Corp.
Cardiovascular · 74d
Cleared Aug 06, 1982
HEART*AID, ALS, MODEL 95
K821673 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 60d
Cleared Aug 06, 1982
POROUS SURFACED PLATINUM IRIDIUM
K821889 · DTB
Cordis Corp.
Cardiovascular · 42d
Cleared Aug 06, 1982
FASTPASS IMPLANTABLE ENDOCARD. PACING
K821947 · DTB
Pacesetter Systems
Cardiovascular · 37d
Cleared Aug 06, 1982
CKG 8000
K822020 · DSB
Cardio Kinetics, Inc.
Cardiovascular · 28d
Cleared Aug 06, 1982
MEDTRONIC ENERTRAX MODEL 7100
K822147 · DXY
Medtronic Vascular
Cardiovascular · 15d
Cleared Aug 06, 1982
NONINVASIVE TEMPORARY PACEMAKER
K822246 · DRO
Ross Research, Inc.
Cardiovascular · 8d
Cleared Jul 30, 1982
EKG (ECG) ELECTRODES
K821434 · DRX
Dupaco, Inc.
Cardiovascular · 79d
Cleared Jul 30, 1982
ARGYLE FERGUSON LEFT ATRIAL VENT CATH
K821445 · DWF
Sherwood Medical Co.
Cardiovascular · 77d
Cleared Jul 30, 1982
CENTURION ELECTRODE BELT
K821802 · DRX
Clinical Data, Inc.
Cardiovascular · 45d
Cleared Jul 30, 1982
LDS MONITORING ELECTRODE
K821846 · DRX
Life Design Systems, Inc.
Cardiovascular · 38d
Cleared Jul 30, 1982
AUTOMATIC SINGLE CHANNEL ECG #399
K821888 · DPS
Birtcher Corp.
Cardiovascular · 35d
Cleared Jul 30, 1982
LEONARD PERIPHERAL VENOUS PRESSURE CATH
K821996 · DYG
Norton Performance Plastics Corp.
Cardiovascular · 23d
Cleared Jul 30, 1982
D645-BACTERIOLOGICAL GAS LINE FILTER
K822097 · KRI
Electromedics, Inc.
Cardiovascular · 14d
Cleared Jul 20, 1982
DISPOSABLE TRANSDUCER DOMES & KITS
K821894 · DRS
American Pharmaseal Div. Ahsc
Cardiovascular · 22d
Cleared Jul 20, 1982
CARDIO-RESPIRATORY MONITOR MODEL CR-1
K821959 · DRT
Electromed Intl., Ltd.
Cardiovascular · 20d
Cleared Jul 20, 1982
ANGIOGRAPHY KIT
K821976 · DQO
Mallinckrodt Critical Care
Cardiovascular · 14d
Cleared Jul 14, 1982
ARGYLE INTRAMEDICUT CATHETER KIT
K821324 · DYB
Sherwood Medical Co.
Cardiovascular · 71d
Cleared Jul 14, 1982
MODEL 16800 TREND RECORDER
K821612 · DSF
Healthdyne, Inc.
Cardiovascular · 42d
Cleared Jul 14, 1982
AS20 MONITORING SYSTEM
K821614 · DXN
Narco Scientific
Cardiovascular · 42d
Cleared Jul 14, 1982
THE SOFT PEDAL
K821696 · JOW
Habco Products, Inc.
Cardiovascular · 36d
Cleared Jul 14, 1982
LITTMAN TUNABLE STETHOSCOPE 2136
K821909 · LDE
3M Company
Cardiovascular · 16d
Cleared Jul 09, 1982
MEADOX WOVEN DOUBLE VELOUR
K820696 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 119d
Cleared Jul 09, 1982
ARGYLE GERZOF ABCESS DRAINAGE CATHETER
K821732
Sherwood Medical Co.
Cardiovascular · 25d