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
8617–8640 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 16, 2001
COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
K013480 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 28d
Cleared Nov 15, 2001
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
K012763 · DRT
Cobe Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Nov 15, 2001
CAPIOX RX HARDSHELL RESERVOIR
K013526 · DTN
Terumo Cardiovascular Systems Corp.
Cardiovascular · 23d
Cleared Nov 14, 2001
N2000 BASE STATION, N2001 NURSE STATION
K012801 · DXN
Neptec Design Group, Ltd.
Cardiovascular · 85d
Cleared Nov 14, 2001
CAROTID GUIDING SHEATH
K012812 · DYB
Terumo Medical Corp.
Cardiovascular · 84d
Cleared Nov 14, 2001
MODIFICATION TO M2376A DEVICELINK SYSTEM
K013470 · MWI
Philips Medical Systems, Inc.
Cardiovascular · 27d
Cleared Nov 09, 2001
TONOPORT V
K012647 · DXN
Par Medizintechnik GmbH
Cardiovascular · 88d
Cleared Nov 09, 2001
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM
K013393 · KFM
A-Med Systems, Inc.
Cardiovascular · 25d
Cleared Nov 08, 2001
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
K012724 · LYK
Smith & Nephew, Inc.
Cardiovascular · 86d
Cleared Nov 08, 2001
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
K013339 · DTB
Oscor, Inc.
Cardiovascular · 30d
Cleared Nov 06, 2001
PF 5050 PRESSURE UNIT, MODEL PF 5050
K011899 · DPW
Perimed AB
Cardiovascular · 141d
Cleared Nov 06, 2001
JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...
K012617 · DWF
Jostra AG
Cardiovascular · 85d
Cleared Nov 05, 2001
THE V BAG, CATALOG NUMBER VB1800
K012942 · DTN
Circulatory Technology, Inc.
Cardiovascular · 66d
Cleared Nov 02, 2001
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
K011439 · DSB
Cardiodynamics International Corp.
Cardiovascular · 176d
Cleared Nov 02, 2001
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX
K012531 · MSX
Datex-Ohmeda
Cardiovascular · 88d
Cleared Nov 02, 2001
MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC,...
K013326 · DSP
Datascope Corp.
Cardiovascular · 28d
Cleared Nov 01, 2001
ADC 656 ELECTRONIC STETHOSCOPE
K012304 · DQD
American Diagnostic Corp.
Cardiovascular · 104d
Cleared Nov 01, 2001
DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM
K012498 · DXN
Pulse Metric, Inc.
Cardiovascular · 90d
Cleared Oct 31, 2001
MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE...
K011761 · DYB
Arrow Intl., Inc.
Cardiovascular · 147d
Cleared Oct 30, 2001
TM2000 EASYTRACE PLUS RECEIVING CENTER
K013175 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 36d
Cleared Oct 26, 2001
STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE
K001509 · DWF
Cobe Cardiovascular, Inc.
Cardiovascular · 529d
Cleared Oct 26, 2001
AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A
K010729 · DQD
Andromed, Inc.
Cardiovascular · 228d
Cleared Oct 26, 2001
BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
K012636 · DXN
Vsm Technology, Inc.
Cardiovascular · 74d
Cleared Oct 26, 2001
GORE-TEX VASCULAR GRAFT
K013250 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 28d