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
8209–8232 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 14, 2002
SEER LIGHT COMPACT DIGITAL HOLTER RECORDER
K021470 · MWJ
General Electric Medical Systems...
Cardiovascular · 190d
Cleared Nov 14, 2002
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A...
K022740 · MLD
Datex-Ohmeda
Cardiovascular · 87d
Cleared Nov 14, 2002
REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
K022753 · JOW
Medical Device Services
Cardiovascular · 87d
Cleared Nov 14, 2002
CARDIOTOUCH-3000
K023034 · LOS
Bionet Company, Ltd.
Cardiovascular · 63d
Cleared Nov 14, 2002
SKINTACT ECG ELECTRODE
K023503 · DRX
Leonhard Lang GmbH
Cardiovascular · 27d
Cleared Nov 13, 2002
QUANTIX/ND DEVICE
K023431 · DPW
Cardiosonix, Ltd.
Cardiovascular · 29d
Cleared Nov 13, 2002
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K023504 · LIT
Cook, Inc.
Cardiovascular · 26d
Cleared Nov 08, 2002
PHILIPS M5066A AND M5068A
K020715 · MKJ
Philips Medical Systems
Cardiovascular · 248d
Cleared Nov 08, 2002
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M
K021239 · DXN
Eikon Healthcare Device Corp.
Cardiovascular · 204d
Cleared Nov 08, 2002
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200
K021240 · DXN
Eikon Healthcare Device Corp.
Cardiovascular · 204d
Cleared Nov 08, 2002
MODIFICATION TO GELBFISH VASCULAR DILATORS
K023507 · DRE
Vascumetrix, LLC
Cardiovascular · 21d
Cleared Nov 07, 2002
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
K020003 · DRX
Bio Protech, Inc.
Cardiovascular · 309d
Cleared Nov 06, 2002
CO-AXIAL INTRODUCER NEEDLE
K022634 · DYB
Promex, Inc.
Cardiovascular · 90d
Cleared Nov 06, 2002
8F LAUNCHER GUIDE CATHETER
K023402 · DQY
Medtronic Vascular
Cardiovascular · 27d
Cleared Nov 06, 2002
HEARTONE EVENT RECORDER AND TRANSMITTER
K023418 · DXH
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 26d
Cleared Nov 04, 2002
PHLEBOTEST 2000
K022047 · JOM
Osborn Medical Corp.
Cardiovascular · 133d
Cleared Nov 04, 2002
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE
K023497 · MSX
Datex-Ohmeda
Cardiovascular · 17d
Cleared Nov 04, 2002
SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS
K023569 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 11d
Cleared Nov 04, 2002
PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
K023616 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 6d
Cleared Oct 31, 2002
MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)
K023447 · DYB
St Jude Medical
Cardiovascular · 16d
Cleared Oct 31, 2002
WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)
K023495 · DXN
Welch Allyn, Inc.
Cardiovascular · 13d
Cleared Oct 29, 2002
EXPORT ASPIRATION CATHETER
K023303 · NFA
Medtronic Vascular
Cardiovascular · 26d
Cleared Oct 28, 2002
ARTERIA OCCLUSION BALLOON
K021210 · MJN
Arteria Medical Science, Inc.
Cardiovascular · 194d
Cleared Oct 28, 2002
HI-TORQUE WHISPER LS
K023300 · DQX
Guidant Corp.
Cardiovascular · 25d