FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×

18,110 results

10009–10032 of 18,110

Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular

Cleared Sep 12, 1997

TELE TRENS TM 10

Life Sensing Instrument Company, Inc.

Cardiovascular · 557d

Cleared Sep 11, 1997

SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM

Siemens Medical Solutions USA, Inc.

Cardiovascular · 303d

Cleared Sep 11, 1997

BIOZ SYSTEM & BIOZ PORTABLE

Cardiodynamics International Corp.

Cardiovascular · 80d

Cleared Sep 10, 1997

MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)

Card Guard , Ltd.

Cardiovascular · 415d

Cleared Sep 10, 1997

S3 CYCLIC RPM CONTROL

Stoeckert Instrumente

Cardiovascular · 138d

Cleared Sep 10, 1997

BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)

Cardiovascular · 103d

Cleared Sep 09, 1997

FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR

Fukuda Denshi USA, Inc.

Cardiovascular · 207d

Cleared Sep 08, 1997

AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS

Cardiovascular · 320d

Cleared Sep 08, 1997

CHASE THORACIC CATHETER

Chase Medical, Inc.

Cardiovascular · 172d

Cleared Sep 03, 1997

VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER

Sorin Biomedical, Inc.

Cardiovascular · 268d

Cleared Sep 02, 1997

30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL

Boston Scientific Corp

Cardiovascular · 89d

Cleared Aug 29, 1997

OPUS S MODEL 4121 AND 4124 PACEMAKERS

Ela Medical, Inc.

Cardiovascular · 233d

Cleared Aug 29, 1997

ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER

Boston Scientific Corp

Cardiovascular · 214d

Cleared Aug 29, 1997

MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM

Paladin Medical, Inc.

Cardiovascular · 214d

Cleared Aug 28, 1997

INFUSASLEEVE IIA (IS-2A)

Cardiovascular · 80d

Cleared Aug 27, 1997

MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE

Graphic Controls Corp.

Cardiovascular · 16d

Cleared Aug 26, 1997

CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE

Sorin Group Italia S.R.L.

Cardiovascular · 54d

Cleared Aug 25, 1997

ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING

Cardiovascular · 80d

Cleared Aug 22, 1997

CHASE BLOOD VESSEL SHUNT

Chase Medical, Inc.

Cardiovascular · 37d

Cleared Aug 21, 1997

VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY...

Sorin Biomedical, Inc.

Cardiovascular · 255d

Cleared Aug 20, 1997

DM-400 HOLTER ECG CASSETTE RECORDER

Diagnostic Monitoring

Cardiovascular · 205d

Cleared Aug 20, 1997

NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A...

Nihon Kohden America, Inc.

Cardiovascular · 61d

Cleared Aug 19, 1997

ORIGIN CARDIAC STABLIZER OCCLUDER

Origin Medsystems, Inc.

Cardiovascular · 182d

Cleared Aug 18, 1997

CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM

Cardio Metrics, Inc.

Cardiovascular · 238d