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
17521–17544 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 30, 1978
ECG ANALYZER, HIGH SPEED
K781911 · DSI
Cardio-Dynamics Laboratories, Inc.
Cardiovascular · 16d
Cleared Nov 29, 1978
CALIBRATOR, DYNAMIC
K781692 · DXM
Waters Assoc., Inc.
Cardiovascular · 56d
Cleared Nov 29, 1978
BLOOD PRESSURE RECORDER
K781932 · DXN
Cardiodyne, Inc.
Cardiovascular · 9d
Cleared Nov 29, 1978
EKG ELECTRODES, DISPOSABLE
K781940 · DRX
Hayes Products, Inc.
Cardiovascular · 9d
Cleared Nov 29, 1978
CATHETER INTRODUCERS, ARTERISE
K781954 · DYB
C.R. Bard, Inc.
Cardiovascular · 8d
Cleared Nov 22, 1978
DELTA-FLOW
K780479 · KRA
Tri-Delta Intl.
Cardiovascular · 240d
Cleared Nov 22, 1978
EXTRACTOR, SABIAN FOREIGN BODY
K781737
Sabian Corp.
Cardiovascular · 41d
Cleared Nov 20, 1978
CAMSCAN SYSTEM
K781845 · DSI
American Optical Corp.
Cardiovascular · 19d
Cleared Nov 16, 1978
BLOOD PRESSURE CUFF COVER
K781671 · DXQ
David Cott Co.
Cardiovascular · 44d
Cleared Nov 16, 1978
BLOOD PRESSURE DEVICE, 400 SERIES
K781906 · DXN
Med-Tek Corp.
Cardiovascular · 3d
Cleared Nov 15, 1978
FILTER, EXTRACORPOREAL BLOOD HOLDER
K781861 · KRI
Surgikos, Inc.
Cardiovascular · 9d
Cleared Nov 08, 1978
OXYGENATOR, BLOOD BOS-10
K781842 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 12d
Cleared Nov 07, 1978
ANGIOGRAPHIC GUIDE WIRE
K781561 · DQX
Wilson Medical Instruments Co.
Cardiovascular · 56d
Cleared Nov 03, 1978
RECORDER, HOLTER ELECTROCARDIOGRAM
K781843 · DSH
Hovik Corp.
Cardiovascular · 2d
Cleared Oct 31, 1978
PREGELLED DISPOSABLE E.K.G. ELECTRODE
K781430 · DRX
Vermont Medical, Inc.
Cardiovascular · 71d
Cleared Oct 30, 1978
VARIABLE STIFFNESS WIRE GUIDE
K781393 · DQX
Cook, Inc.
Cardiovascular · 81d
Cleared Oct 27, 1978
STRAIN GAUGE PLETHYSMOGRAPH
K781352 · DSB
Medimatic
Cardiovascular · 81d
Cleared Oct 27, 1978
PACING LEADS MODEL UL-811 AND UL-813
K781776 · DTB
Pacesetter Systems
Cardiovascular · 14d
Cleared Oct 26, 1978
FILTER, ARTERIAL BLOOD W/TUBING BYPASS
K781707 · DTM
Surgikos, Inc.
Cardiovascular · 16d
Cleared Oct 18, 1978
PACEMAKER, MODEL 251-01
K781568
Intermedics, Inc.
Cardiovascular · 34d
Cleared Oct 17, 1978
ECG ELECTRODE, 2021, 2022, 2032, 2033
K781514 · DRX
Cardio-Dynamics Laboratories, Inc.
Cardiovascular · 46d
Cleared Oct 17, 1978
PRESSURE INFUSION CUFF
K781556 · DXN
Abbott Laboratories
Cardiovascular · 36d
Cleared Oct 15, 1978
MONITOR, HEART RATE
K781166 · DRT
Cybernetic Medical, Inc.
Cardiovascular · 95d
Cleared Oct 11, 1978
C.P.R. COUNTING PACER
K781636
Qual-Tec, Inc.
Cardiovascular · 19d