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
7489–7512 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 15, 2004
GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3
K042771 · MSX
Datex-Ohmeda
Cardiovascular · 10d
Cleared Oct 13, 2004
AMLUCK, YA HORNG
K042581 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 21d
Cleared Oct 12, 2004
KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND...
K031728 · DWJ
Klimamed Technologie Medizingerate GmbH
Cardiovascular · 496d
Cleared Oct 12, 2004
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K042541 · DQY
Cryo Vascular Systems, Inc.
Cardiovascular · 22d
Cleared Oct 12, 2004
BIOMEDIX PADNET LAB
K042616 · JOM
Biomedix, Inc.
Cardiovascular · 19d
Cleared Oct 06, 2004
MPM SYSTEM
K041854 · DXN
Aerotel Medical Systems, Ltd.
Cardiovascular · 90d
Cleared Oct 06, 2004
EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE
K042060 · DTL
Millimed A/S
Cardiovascular · 68d
Cleared Oct 06, 2004
CARDEON COBRA CATHETER
K042156 · DWF
Cardeon Corp.
Cardiovascular · 57d
Cleared Oct 06, 2004
BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER
K042469 · MWJ
Braemar, Inc.
Cardiovascular · 23d
Cleared Oct 06, 2004
STELLAR 404 MONITORING SYSTEM
K042560 · MWI
Larsen & Toubro Limited
Cardiovascular · 15d
Cleared Oct 06, 2004
INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5
K042656 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 8d
Cleared Oct 05, 2004
ZOLL M SERIES ETC02 LOFLO OPTION
K042417 · MKJ
Zoll Medical Corp
Cardiovascular · 28d
Cleared Sep 29, 2004
8600 VITAL SIGNS MONITOR
K042569 · MWI
Criticare Systems, Inc.
Cardiovascular · 8d
Cleared Sep 23, 2004
VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)
K041909 · DQO
Vascular Solutions, Inc.
Cardiovascular · 70d
Cleared Sep 23, 2004
CLIPPER DIAGNOSTIC ELECTRODE CATHETER
K042105 · DRF
Bard Electrophysiology
Cardiovascular · 50d
Cleared Sep 23, 2004
STOCKERT SCP RHYTHM
K042374 · DWA
Stockert Instrumente GmbH
Cardiovascular · 22d
Cleared Sep 23, 2004
Lysus Infusion System
K042456 · QEY
Ekos Corp.
Cardiovascular · 13d
Cleared Sep 22, 2004
MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M
K040915 · MWI
Invivo Research, Inc.
Cardiovascular · 167d
Cleared Sep 22, 2004
AMBU DISPOSABLE ECG ELECTRODE
K041734 · DRX
Ambu, Inc.
Cardiovascular · 89d
Cleared Sep 22, 2004
CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
K041890 · OCL
Cryocor, Inc.
Cardiovascular · 72d
Cleared Sep 22, 2004
HOLTER PLUS
K042463 · DQK
Rozinn Electronics, Inc.
Cardiovascular · 9d
Cleared Sep 20, 2004
ZEWA MFM-007 BLOOD PRESSURE MONITOR
K041491 · DXN
Zewa, Inc.
Cardiovascular · 108d
Cleared Sep 16, 2004
PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
K040904 · NSA
Philips Medical Systems
Cardiovascular · 162d
Cleared Sep 16, 2004
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
K042338 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 17d