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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×

18,027 results

11569–11592 of 18,027

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

Cleared Jan 06, 1993

ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION

Cardiovascular · 211d

Cleared Jan 06, 1993

COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600

Baxter Healthcare Corp

Cardiovascular · 181d

Cleared Jan 05, 1993

COBE PATIENT MONITORING PRODUCTS

Cobe Cardiovascular, Inc.

Cardiovascular · 292d

Cleared Dec 30, 1992

PRESSSION, SEQUENTIAL

Chattanooga Group, Inc.

Cardiovascular · 271d

Cleared Dec 29, 1992

MARQUETTE SV O2 MODULE

Marquette Electronics, Inc.

Cardiovascular · 417d

Cleared Dec 29, 1992

MARQUETTE SERIES 360 DEFIBRILLATOR

Marquette Electronics, Inc.

Cardiovascular · 274d

Cleared Dec 28, 1992

CENTRA II ANALYSIS SYSTEM

Marquette Electronics, Inc.

Cardiovascular · 234d

Cleared Dec 24, 1992

OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601

Omron Healthcare, Inc.

Cardiovascular · 308d

Cleared Dec 23, 1992

OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706

Omron Healthcare, Inc.

Cardiovascular · 425d

Cleared Dec 23, 1992

VENOUS RESERVOIR W/CARDIOTOMY FILTER

Baxter Healthcare Corp

Cardiovascular · 377d

Cleared Dec 23, 1992

MODEL 4280 SURGICAL EXTENSION CABLE

Cardiovascular · 190d

Cleared Dec 21, 1992

ROADRUNNER(TM) WIRE GUIDE, MODIFICATION

Cardiovascular · 301d

Cleared Dec 21, 1992

NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE

Meadox Medicals, Div. Boston...

Cardiovascular · 200d

Cleared Dec 21, 1992

DIAGNOSTIC INTRAVASCULAR CATHETER

Applied Vascular

Cardiovascular · 150d

Cleared Dec 18, 1992

BSM-8800A BEDSIDE MONITOR

Nihon Kohden America, Inc.

Cardiovascular · 340d

Cleared Dec 18, 1992

RMI EXTERNAL CORONARY ARTERY OCCLUDER

Research Medical, Inc.

Cardiovascular · 294d

Cleared Dec 17, 1992

ES 1500 ECG DEMODULATOR

Epic Systems, Inc.

Cardiovascular · 253d

Cleared Dec 15, 1992

ZYMED TELEMETRY MONITOR MODEL T8010 (PRELIMINARY)

Agilent Technologies

Cardiovascular · 90d

Cleared Dec 11, 1992

ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK

Advance Medical Designs, Inc.

Cardiovascular · 386d

Cleared Dec 11, 1992

MERITRANS(TM) DISPOSABLE TRANSDUCER

Merit Medical Systems, Inc.

Cardiovascular · 284d

Cleared Dec 11, 1992

Adroit Medical Systems, Inc.

Cardiovascular · 232d

Cleared Dec 10, 1992

Procedure Products, Inc.

Cardiovascular · 196d

Cleared Dec 10, 1992

SCIMED SIDELINER

Cardiovascular · 188d

Cleared Dec 08, 1992

RMI NORMOCLUDER CORONARY ARTERY OCCLUDER

Research Medical, Inc.

Cardiovascular · 343d