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
7849–7872 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 29, 2003
XTRAK SUPPORT CATHETER
K032660 · DQY
Xtrak Medical, Inc.
Cardiovascular · 62d
Cleared Oct 29, 2003
DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE
K033078 · MSX
Datex-Ohmeda
Cardiovascular · 30d
Cleared Oct 27, 2003
CENTRA VIEW DEVICE LINK SYSTEM
K033283 · MWI
Icu Datasystems, Inc.
Cardiovascular · 13d
Cleared Oct 23, 2003
FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1
K023723 · DXN
Fms, Finapres Medical Systems BV
Cardiovascular · 352d
Cleared Oct 23, 2003
ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110
K030627 · DRF
C.R. Bard, Inc.
Cardiovascular · 238d
Cleared Oct 22, 2003
REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH
K032632 · DWF
Estech, Inc.
Cardiovascular · 57d
Cleared Oct 22, 2003
PTA BALLOON CATHETER
K032931 · DQY
Cook, Inc.
Cardiovascular · 30d
Cleared Oct 21, 2003
ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
K032312 · DQY
Medtronic Vascular
Cardiovascular · 85d
Cleared Oct 17, 2003
RADIUS COUGAR WIRE
K032899 · DQX
Radius Medical Technologies, Inc.
Cardiovascular · 30d
Cleared Oct 16, 2003
UUHC REPROCESSED COMPRESSION SLEEVE DEVICES
K031189 · JOW
University of Utah Hospitals and Clinics
Cardiovascular · 184d
Cleared Oct 15, 2003
DIGITAL AMBULATORY ECG (HOLTER) RECORDER
K031074 · MWJ
Datrix
Cardiovascular · 194d
Cleared Oct 15, 2003
EKG SPEAKS
K032926 · KRE
Medtronic Vascular
Cardiovascular · 23d
Cleared Oct 15, 2003
MODIFICATION TO: HORIZON 9000WS
K032997 · DXG
Mennen Medical , Ltd.
Cardiovascular · 20d
Cleared Oct 14, 2003
EKOS PERIPHERAL INFUSION SYSTEM
K033214 · QEY
Ekos Corp.
Cardiovascular · 11d
Cleared Oct 10, 2003
CUF-COVER (TM)
K031195 · DXQ
Ethox Corp.
Cardiovascular · 177d
Cleared Oct 10, 2003
VIEWPOINT TELEMETRY SYSTEM
K031760 · MHX
Datascope Corp.
Cardiovascular · 126d
Cleared Oct 10, 2003
CAREMATIX WELLNESS SYSTEM
K031840 · DXN
Carematix, Inc.
Cardiovascular · 116d
Cleared Oct 10, 2003
CARESTATION 126S VIDEOPHONE
K031863 · MWI
Motion Media Technology, Inc.
Cardiovascular · 116d
Cleared Oct 10, 2003
FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR
K032290 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 78d
Cleared Oct 10, 2003
MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
K032577 · DQK
Ge Medical Systems Information...
Cardiovascular · 50d
Cleared Oct 10, 2003
HL888BM
K032837 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Oct 10, 2003
HL888BA
K032839 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Oct 10, 2003
THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS,...
K032858 · DSI
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 28d
Cleared Oct 10, 2003
MODIFICATION TO HL168
K033043 · DXN
Health & Life Co., Ltd.
Cardiovascular · 11d