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

9865–9888 of 18,110

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

Cleared Feb 19, 1998

M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT...

Hewlett-Packard Co.

Cardiovascular · 87d

Cleared Feb 19, 1998

SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER

Scimed Life Systems, Inc.

Cardiovascular · 65d

Cleared Feb 18, 1998

AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE

Avecor Cardiovascular, Inc.

Cardiovascular · 139d

Cleared Feb 17, 1998

OBSERVER * CENTRAL STATION

Johnson & Johnson Medical, Inc.

Cardiovascular · 229d

Cleared Feb 13, 1998

ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET

Arrow Intl., Inc.

Cardiovascular · 388d

Cleared Feb 13, 1998

HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS...

Healthcare Service and Supply

Cardiovascular · 88d

Cleared Feb 13, 1998

EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.

J-Lloyd Medical, Inc.

Cardiovascular · 87d

Cleared Feb 12, 1998

SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL

Boston Scientific Scimed, Inc.

Cardiovascular · 220d

Cleared Feb 11, 1998

ENSEMBLE CENTRAL STATION MONITOR

Mennen Medical, Inc.

Cardiovascular · 377d

Cleared Feb 10, 1998

Golden Gate Bio-Device

Cardiovascular · 138d

Cleared Feb 10, 1998

CES MASSTRANSIT INFUSION CATHETER

Cordis Neurovascular, Inc.

Cardiovascular · 90d

Cleared Feb 10, 1998

Boston Scientific Corp

Cardiovascular · 90d

Cleared Feb 06, 1998

HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01)

Himex Production Corp.

Cardiovascular · 199d

Cleared Feb 06, 1998

THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)

Micro Therapeutics, Inc.

Cardiovascular · 134d

Cleared Feb 06, 1998

DATEX-ENGSTROM NETWORK

Datex-Engstrom, Inc.

Cardiovascular · 99d

Cleared Feb 06, 1998

ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION

Marquette Medical Systems, Inc.

Cardiovascular · 88d

Cleared Feb 06, 1998

CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

Cardiovascular · 73d

Cleared Feb 03, 1998

CRYOGEN CARDIAC CRYOSURGICAL SYSTEM

Cardiovascular · 78d

Cleared Jan 30, 1998

VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK...

Pace Tech Medical Monitors, Inc.

Cardiovascular · 359d

Cleared Jan 29, 1998

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER

Galix Biomedical Instrumentation, Inc.

Cardiovascular · 268d

Cleared Jan 29, 1998

TTM5000 TELEPHONIC EKG MONITOR

Hds Medical, Inc.

Cardiovascular · 153d

Cleared Jan 27, 1998

BIOSPECTROMETER-NB OXIMETER IIII

Hutchinson Technology, Inc.

Cardiovascular · 484d

Not Cleared Jan 27, 1998

ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606

Biotronik, Inc.

Cardiovascular · 403d

Cleared Jan 27, 1998

COBE OXYGENATOR PRODUCTS

Cobe Cardiovascular, Inc.

Cardiovascular · 90d