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
7873–7896 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 07, 2003
JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE
K032411 · DQX
Js Vascular, Inc.
Cardiovascular · 63d
Cleared Oct 03, 2003
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K030279 · NLH
Alliance Medical Corp.
Cardiovascular · 249d
Cleared Oct 03, 2003
ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH
K032200 · DPS
Remco Italia S.P.A.
Cardiovascular · 77d
Cleared Oct 03, 2003
HEART 2006
K032736 · DXH
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 29d
Cleared Oct 02, 2003
EDWARDS PERIPHERAL DILATATION CATHETER
K032587 · DQY
Edwards Lifesciences, LLC
Cardiovascular · 41d
Cleared Oct 02, 2003
HL888BF
K032695 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Oct 02, 2003
CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA...
K032737 · DQY
Cordis Europa, N.V.
Cardiovascular · 28d
Cleared Oct 02, 2003
HL888 AF
K032913 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Oct 01, 2003
CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W
K031922 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 100d
Cleared Sep 30, 2003
VASCUPUNCTURE PICC GUIDEWIRE
K031652 · DQX
Neometrics, Inc.
Cardiovascular · 125d
Cleared Sep 25, 2003
RINSPIRATION SYSTEM
K031485 · DQO
Kerberos Proximal Solutions
Cardiovascular · 136d
Cleared Sep 25, 2003
NUMED TYSHAK MINI PEDIATRIC PTV CATHETER
K032591 · DQY
NuMED, Inc.
Cardiovascular · 34d
Cleared Sep 24, 2003
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K030187 · NLH
Alliance Medical, Inc.
Cardiovascular · 246d
Cleared Sep 17, 2003
GALIX WINTER
K030145 · DQK
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 245d
Cleared Sep 17, 2003
UNITY NETWORK PATIENT DATA SERVER
K032582 · MSX
Ge Medical Systems Information...
Cardiovascular · 27d
Cleared Sep 16, 2003
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060
K030504 · MCW
Idev Technologies, Inc.
Cardiovascular · 209d
Cleared Sep 16, 2003
PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16
K031948 · DXZ
Pm Devices, Inc.
Cardiovascular · 84d
Cleared Sep 16, 2003
SHORT INTRODUCER SHEATH
K032569 · DYB
Rex Medical
Cardiovascular · 27d
Cleared Sep 16, 2003
ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
K032615 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 22d
Cleared Sep 16, 2003
BEDSIDE MONITOR, MODEL OPV-1500
K032749 · MWI
Nihon Kohden America, Inc.
Cardiovascular · 11d
Cleared Sep 10, 2003
PATHWAY ACCESS SHEATH CATHETER
K030734 · DYB
Vertelink Corporation
Cardiovascular · 184d
Cleared Sep 10, 2003
SELDINGER SAFETY NEEDLE INTRODUCER
K032404 · DYB
Hdc Corp.
Cardiovascular · 37d
Cleared Sep 10, 2003
MICRUS MICROCATHETER
K032624 · DQO
Micrus Corp.
Cardiovascular · 15d
Cleared Sep 09, 2003
AMPLATZER VASCULAR PLUG
K031810 · KRD
Aga Medical Corp.
Cardiovascular · 89d