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
6505–6528 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 21, 2007
PLANET 55
K071472 · MWI
Larsen & Toubro Limited
Cardiovascular · 115d
Cleared Sep 19, 2007
PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
K072364 · KRB
Pulsion Medical Systems AG
Cardiovascular · 28d
Cleared Sep 19, 2007
DORADO PTA BALLOON DILATATION CATHETER
K072283 · DQY
Bard Peripheral Vascular, Inc.
Cardiovascular · 34d
Cleared Sep 19, 2007
PULL TAB SQUEEZE FLUSH
K070979 · KRA
Icu Medical, Inc.
Cardiovascular · 166d
Cleared Sep 19, 2007
PERIPHERAL GUIDING SHEATH
K070816 · DYB
Micrus Design Technology, Inc.
Cardiovascular · 177d
Cleared Sep 19, 2007
PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112
K063735 · DRT
Presym, Inc.
Cardiovascular · 275d
Cleared Sep 18, 2007
MODIFICATION TO HYPERQ SYSTEM
K072389 · MWI
Biological Signal Processing, Ltd.
Cardiovascular · 25d
Cleared Sep 17, 2007
PRECIOUS PLUS GUIDE CATHETER
K072316 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 31d
Cleared Sep 13, 2007
BRK TRANSSEPTAL NEEDLE
K072278 · DRC
St Jude Medical
Cardiovascular · 28d
Cleared Sep 12, 2007
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN...
K072308 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 26d
Cleared Sep 12, 2007
BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM
K072297 · DXC
Cardiva Medical, Inc.
Cardiovascular · 26d
Cleared Sep 12, 2007
POCKETCPR
K071321 · LIX
Bio-Detek, Inc.
Cardiovascular · 125d
Cleared Sep 12, 2007
INTRAVASCULAR INTRODUCER SYSTEM
K063658 · DYB
Applied Medical Resources Corp.
Cardiovascular · 278d
Cleared Sep 12, 2007
RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
K063609 · DXH
Shl Telemedicine International , Ltd.
Cardiovascular · 282d
Cleared Sep 08, 2007
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552
K072269 · QEZ
Possis Medical, Inc.
Cardiovascular · 24d
Cleared Sep 07, 2007
HONEYWELL HOMMED CENTRAL STATION 4.0
K072272 · DXN
Honeywell Hommed, LLC
Cardiovascular · 23d
Cleared Sep 07, 2007
CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR
K071911 · DQK
Innovision A/S
Cardiovascular · 58d
Cleared Sep 07, 2007
PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
K071391 · MSX
Philips Medical Systems, Inc.
Cardiovascular · 112d
Cleared Sep 07, 2007
EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM
K071348 · DQK
Mennen Medical , Ltd.
Cardiovascular · 116d
Cleared Sep 06, 2007
COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE
K072167 · DXC
Advanced Vascular Dynamics
Cardiovascular · 31d
Cleared Sep 06, 2007
DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS
K071196 · DQO
Coeur, Inc.
Cardiovascular · 129d
Cleared Aug 31, 2007
JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE
K072172 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 25d
Cleared Aug 31, 2007
VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900
K071660 · OBJ
Volcano Corporation
Cardiovascular · 74d
Cleared Aug 31, 2007
BIOSIGN CENTRAL STATION
K071606 · MWI
Obs Medical
Cardiovascular · 80d