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
6985–7008 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 07, 2006
MACTRODE 3
K060661 · DRX
Ge Medical Systems Information...
Cardiovascular · 25d
Cleared Apr 07, 2006
HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K060315 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 58d
Cleared Apr 07, 2006
RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1
K051227 · JOW
Renu Medical, Inc.
Cardiovascular · 330d
Cleared Apr 06, 2006
AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
K060309 · DSP
Arrow Intl., Inc.
Cardiovascular · 58d
Cleared Apr 05, 2006
SWIRLGRAFT VASCULAR ACCESS GRAFT
K060741 · DSY
Veryan Medical Limited
Cardiovascular · 16d
Cleared Apr 05, 2006
TRAM MODULE
K053121 · MHX
Ge Healthcare
Cardiovascular · 149d
Cleared Apr 04, 2006
PMP4 BP PRO BLOOD PRESSURE MONITOR
K060703 · DXN
Card Guard Scientific Survival , Ltd.
Cardiovascular · 19d
Cleared Apr 04, 2006
SCOUTPRO 8F, MODELS 342 262
K060655 · DQY
Biotronik, Inc.
Cardiovascular · 22d
Cleared Apr 04, 2006
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K
K060342 · DXN
Rossmax International , Ltd.
Cardiovascular · 53d
Cleared Apr 04, 2006
MODIFICATION TO INFINITY EXPLORER
K060254 · MSX
Draeger Medical Systems, Inc.
Cardiovascular · 62d
Cleared Apr 04, 2006
SUPER SHEATH XL INTRODUCER SHEATH
K060190 · DYB
Togo Medikit Co., Ltd.
Cardiovascular · 70d
Cleared Apr 04, 2006
VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)
K051438 · JOW
Alliance Medical, Inc.
Cardiovascular · 307d
Cleared Mar 30, 2006
ATRIUM FLIXENE GRAFT
K060124 · DSY
Atrium Medical Corp.
Cardiovascular · 71d
Cleared Mar 30, 2006
RF TUNNELER WIRE
K051670 · PDU
Baylis Medical Co., Inc.
Cardiovascular · 281d
Cleared Mar 29, 2006
ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28
K060197 · DQD
Zargis Medical Corp.
Cardiovascular · 62d
Cleared Mar 28, 2006
SYVEKEXCEL
K053300 · DXC
Marine Polymer Technologies, Inc.
Cardiovascular · 123d
Cleared Mar 28, 2006
IQMARK EZ STRESS
K052898 · DPS
Brentwood Medical Technology Corp.
Cardiovascular · 165d
Cleared Mar 24, 2006
THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT...
K060541 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 23d
Cleared Mar 24, 2006
TITAN GUIDEWIRE
K060454 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 30d
Cleared Mar 24, 2006
ISIGHT IMAGING CATHETER, MODEL 38986
K060175 · DQO
Boston Scientific Corp
Cardiovascular · 60d
Cleared Mar 21, 2006
INQUIRY AFOCUS II DIAGNOSTIC CATHETER
K053582 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 88d
Cleared Mar 20, 2006
KAVS - CATHETER, MODELS 1107100 & 1107060
K052844 · MJN
Richter & Rothe AG
Cardiovascular · 164d
Cleared Mar 16, 2006
ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM
K053431 · DQY
Medtronic, Ireland
Cardiovascular · 97d
Cleared Mar 15, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K060572 · DQY
Boston Scientific Corporation
Cardiovascular · 9d