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
5041–5064 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 18, 2011
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER
K110076 · OWQ
Sterilmed, Inc.
Cardiovascular · 219d
Cleared Aug 17, 2011
CROSSER RECANALIZATION SYSTEM
K112308 · PDU
C.R. Bard, Inc.
Cardiovascular · 6d
Cleared Aug 17, 2011
GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX,...
K112281 · DQY
Trireme Medical, Inc.
Cardiovascular · 8d
Cleared Aug 17, 2011
FIBERNET EMBOLIC PROTECTION DEVICE
K111987 · NTE
Lumen Biomedical, Inc.
Cardiovascular · 35d
Cleared Aug 17, 2011
ZOLL E SERIES
K111594 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 71d
Cleared Aug 17, 2011
FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM
K111284 · LOX
Ostial Corporation
Cardiovascular · 103d
Cleared Aug 12, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K112103 · KRD
Boston Scientific Corp
Cardiovascular · 21d
Cleared Aug 11, 2011
WILDCAT CATHETER
K111338 · PDU
Avinger, Inc.
Cardiovascular · 91d
Cleared Aug 10, 2011
BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER
K111963 · DQY
Bridgepoint Medical
Cardiovascular · 30d
Cleared Aug 09, 2011
SAPPHIRE
K103657 · LOX
Orbusneich Medical, Inc.
Cardiovascular · 237d
Cleared Aug 05, 2011
ECG-6 SERIES ELECTROCARDIOGRAPH
K112135 · DPS
Advanced Instrumentations, Inc.
Cardiovascular · 10d
Cleared Aug 05, 2011
HEADWAY 27 MICROCATHETER
K110813 · DQY
MicroVention, Inc.
Cardiovascular · 134d
Cleared Aug 03, 2011
EKOSONIC ENDOVASCULAR SYSTEM
K111705 · QEY
Ekos Corporation
Cardiovascular · 47d
Cleared Aug 03, 2011
TELEMEDCARE HEALTH MONITOR
K103796 · DRG
Telemedcare Pty, Ltd.
Cardiovascular · 219d
Cleared Aug 02, 2011
ANCHORWIRE GUIDEWIRE
K111288 · DQX
Lake Region Medical
Cardiovascular · 88d
Cleared Aug 01, 2011
KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER
K111745 · DSH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 41d
Cleared Aug 01, 2011
A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS
K111686 · DXN
A&D Company, Ltd.
Cardiovascular · 46d
Cleared Aug 01, 2011
PRIMEWIRE PRESTIGE PLUS
K111395 · DQX
Volcano Corporation
Cardiovascular · 74d
Cleared Aug 01, 2011
BENELLI ACCESS DEVICE
K111334 · DQY
Vascular Solutions, Inc.
Cardiovascular · 81d
Cleared Aug 01, 2011
INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)
K111160 · DSI
Intricon Datrix Corporation
Cardiovascular · 98d
Cleared Jul 29, 2011
OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
K111884 · MGZ
LeMaitre Vascular, Inc.
Cardiovascular · 28d
Cleared Jul 29, 2011
GLIDECROSS SUPPORT CATHETER
K111556 · DQY
Terumo Medical Corp.
Cardiovascular · 53d
Cleared Jul 27, 2011
AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA...
K111972 · KFM
Medtronic, Inc.
Cardiovascular · 16d
Cleared Jul 27, 2011
AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,
K110156 · DXN
Contec Medical System Co., Ltd.
Cardiovascular · 189d