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
5377–5400 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 27, 2010
PERCU-PRO GUIDEWIRE
K094062 · DQX
Cardiosolutions, Inc.
Cardiovascular · 270d
Cleared Sep 24, 2010
PATIENT MONITOR
K102040 · MHX
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 67d
Cleared Sep 23, 2010
NEOWIRE PTA/PTCA GUIDEWIRE
K101729 · DQX
Neometrics, Inc.
Cardiovascular · 94d
Cleared Sep 23, 2010
GUIDE CATHETERS AND ACCESSORIES
K101015 · DQY
Thomas Medical Products, Inc.
Cardiovascular · 164d
Cleared Sep 23, 2010
ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE
K091561 · MKJ
ZOLL Medical Corporation
Cardiovascular · 483d
Cleared Sep 22, 2010
ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S
K100578 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 205d
Cleared Sep 21, 2010
CRITICAL CARE ASSESSMENT
K101983 · JOM
Critical Patient Care, Inc.
Cardiovascular · 69d
Cleared Sep 20, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534
K102356 · DXN
Andon Health Co, Ltd.
Cardiovascular · 32d
Cleared Sep 20, 2010
ALBOSURE POLYESTER VASCULAR PATCH
K101740 · DXZ
LeMaitre Vascular, Inc.
Cardiovascular · 91d
Cleared Sep 20, 2010
BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
K101589 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 105d
Cleared Sep 20, 2010
WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B,...
K100969 · JOW
Wmi Enterprises, LLC
Cardiovascular · 165d
Cleared Sep 20, 2010
GERATHERM UNIQUERESC
K093694 · DWJ
Geratherm Medical AG
Cardiovascular · 294d
Cleared Sep 17, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513
K102353 · DXN
Andon Health Co, Ltd.
Cardiovascular · 29d
Cleared Sep 15, 2010
ZOLL PROPAQ M
K102174 · DRT
Zoll Medical Corporation, World Wide...
Cardiovascular · 44d
Cleared Sep 15, 2010
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
K101968 · MXC
St Jude Medical
Cardiovascular · 65d
Cleared Sep 10, 2010
TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET
K102430 · DSA
Tyco Electronics Corporation
Cardiovascular · 15d
Cleared Sep 10, 2010
BLOOD PRESSURE METER, MODEL CH-658
K102303 · DXN
Citizen Systems Japan Co., Ltd.
Cardiovascular · 25d
Cleared Sep 10, 2010
ENDEAVOUR MONITORING SYSTEM
K102004 · MHX
Mindray DS USA, Inc.
Cardiovascular · 57d
Cleared Sep 10, 2010
ACTA VESSEL OCCLUSION SYSTEM (VOS)
K091952 · KRD
Nfocus Neuromedical, Inc.
Cardiovascular · 436d
Cleared Sep 09, 2010
MEDTRONIC C315 DELIVERY CATHETER
K101885 · DQY
Medtronic, Inc.
Cardiovascular · 65d
Cleared Sep 07, 2010
6F ENGAGE/ENGAGE TR INTRODUCER
K101883 · DYB
St Jude Medical
Cardiovascular · 63d
Cleared Sep 03, 2010
CRUISER 18 GUIDEWIRE
K102211 · DQX
Brivant, Ltd.
Cardiovascular · 29d
Cleared Sep 03, 2010
3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM
K101834 · DRG
3M Company
Cardiovascular · 64d
Cleared Sep 03, 2010
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED),...
K101186 · DTP
Medtronic Perfusion Systems
Cardiovascular · 128d