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

8329–8352 of 18,110

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

Cleared Jul 19, 2002

DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE

Cardiovascular · 88d

Cleared Jul 18, 2002

REPROCESSED FEMORAL COMPRESSION DEVICE

Sterilmed, Inc.

Cardiovascular · 343d

Cleared Jul 18, 2002

GALT MEDICAL GUIDEWIRE

Galt Medical Corp.

Cardiovascular · 30d

Cleared Jul 16, 2002

CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000

Cambridge Heart, Inc.

Cardiovascular · 14d

Cleared Jul 16, 2002

HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS

Cambridge Heart, Inc.

Cardiovascular · 14d

Cleared Jul 12, 2002

ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711

Abbott Laboratories

Cardiovascular · 35d

Cleared Jul 11, 2002

ILT TORQUER, MODEL 114TR1

Intra Luminal Therapeutics, Inc.

Cardiovascular · 83d

Cleared Jul 10, 2002

CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072

Concentric Medical, Inc.

Cardiovascular · 30d

Cleared Jul 09, 2002

Cardiovascular · 266d

Cleared Jul 09, 2002

EASI 12 LEAD ALGORITHM

Philips Medical Systems

Cardiovascular · 148d

Cleared Jul 09, 2002

BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM

Augustine Medical, Inc.

Cardiovascular · 62d

Cleared Jul 03, 2002

INTROCAN SAFETY IV CATHETER

B.Braun Medical, Inc.

Cardiovascular · 90d

Cleared Jul 03, 2002

MAC-LAB/CARDIOLAB EP/COMBOLAB

General Electric Medical Systems...

Cardiovascular · 64d

Cleared Jul 03, 2002

HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A

Philips Medical Systems

Cardiovascular · 58d

Cleared Jul 03, 2002

TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM...

Bacchus Vascular, Inc.

Cardiovascular · 19d

Cleared Jul 02, 2002

MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000

Millar Instruments, Inc.

Cardiovascular · 280d

Cleared Jul 02, 2002

DINAMAP PROCARE SERIES MONITOR

Ge Medical Systems Information...

Cardiovascular · 188d

Cleared Jul 02, 2002

SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM

Cobe Cardiovascular, Inc.

Cardiovascular · 28d

Cleared Jun 28, 2002

BODY FORCE, MODEL BT 6000

Composites Solutions, Inc.

Cardiovascular · 157d

Cleared Jun 28, 2002

BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA

Cardiovascular · 143d

Cleared Jun 28, 2002

QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52

Spacelabs Medical, Inc.

Cardiovascular · 85d

Cleared Jun 28, 2002

MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL...

Microlife Corp.

Cardiovascular · 65d

Cleared Jun 27, 2002

H12+HOLTER RECORDER

Mortara Instrument, Inc.

Cardiovascular · 57d

Cleared Jun 27, 2002

WELCH ALLYN ABPM 6100

Welch Allyn, Inc.

Cardiovascular · 29d