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
6889–6912 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 12, 2006
GALAXY
K061816 · MWI
Larsen & Toubro Limited
Cardiovascular · 14d
Cleared Jul 12, 2006
INSPECTRA STO2 TISSUE OXYGENATION MONITOR
K061619 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 33d
Cleared Jul 12, 2006
ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
K061593 · OCL
AtriCure, Inc.
Cardiovascular · 34d
Cleared Jul 12, 2006
TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM
K061452 · DXN
Tung FU Electric Co., Ltd.
Cardiovascular · 48d
Cleared Jul 12, 2006
AGILIS NXT STEERABLE INTRODUCER
K061363 · DYB
St Jude Medical
Cardiovascular · 57d
Cleared Jul 12, 2006
QL LOCKING SYRINGE
K060643 · MAV
Atrion Medical Products, Inc.
Cardiovascular · 124d
Cleared Jul 11, 2006
TRIACTIV FX EMBOLIC PROTECTION SYSTEM
K061772 · NFA
Kensey Nash Corp.
Cardiovascular · 18d
Cleared Jul 10, 2006
BIOTRONIK ENDOCARDIAL PACING LEADS
K061212 · DTB
Biotronik, Inc.
Cardiovascular · 70d
Cleared Jul 07, 2006
STARCLOSE INTRODUCER SET MODEL- 1002
K060902 · DYB
Abbott Vascular, Inc.
Cardiovascular · 95d
Cleared Jun 30, 2006
LBI CATHETER SYSTEM
K053372 · QEZ
Lumen Biomedical, Inc.
Cardiovascular · 207d
Cleared Jun 29, 2006
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U
K061558 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 24d
Cleared Jun 29, 2006
Y-CLICK CONNECTOR
K060759 · DTL
Elcam Medical Acal
Cardiovascular · 100d
Cleared Jun 29, 2006
CAROTID ACCESS KIT
K060666 · DYB
Terumo Medical Corp.
Cardiovascular · 107d
Cleared Jun 29, 2006
GERATHERM SOS-RESCUE BAG
K051336 · DWJ
R.G. Enterprises, Inc.
Cardiovascular · 402d
Cleared Jun 29, 2006
GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)
K051278 · DWJ
Rg Ent., Inc.
Cardiovascular · 408d
Cleared Jun 27, 2006
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
K061527 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 25d
Cleared Jun 26, 2006
BLOOD PRESSURE METER, MODEL CH-311B
K061161 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 61d
Cleared Jun 26, 2006
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN
K061159 · DQE
Hospira, Inc.
Cardiovascular · 61d
Cleared Jun 23, 2006
EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222
K061254 · DWF
Medtronic Perfusion Systems
Cardiovascular · 50d
Cleared Jun 23, 2006
ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY
K060745 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 95d
Cleared Jun 23, 2006
VS-800 VITAL SIGNS MONITOR
K060281 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 140d
Cleared Jun 23, 2006
SPIDERX EMBOLIC PROTECTION DEVICE
K053195 · NFA
Ev3, Inc.
Cardiovascular · 220d
Cleared Jun 23, 2006
INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
K052908 · DQO
Infraredx, Inc.
Cardiovascular · 252d
Cleared Jun 23, 2006
AFIBALERT ATRIAL FIBRILLATION DETECTOR
K052767 · DXH
Lechnologies Research, Inc.
Cardiovascular · 266d