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
6649–6672 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 11, 2007
EP-WORKMATE
K070706 · DQK
Ep Medsystems
Cardiovascular · 28d
Cleared Apr 11, 2007
HYPERVISOR VI CENTRAL MONITORING SYSTEM
K062194 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 254d
Cleared Apr 06, 2007
MEDILOGAR4, MEDILOGAR12
K070818 · DSH
Tom Medical Entwicklungs GmbH
Cardiovascular · 11d
Cleared Apr 06, 2007
HYPERQ SYSTEM
K070624 · MWI
Biological Signal Processing, Ltd.
Cardiovascular · 31d
Cleared Apr 06, 2007
STRADA CAROTID GUIDING SHEATH
K070166 · DYB
St Jude Medical
Cardiovascular · 78d
Cleared Apr 06, 2007
ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM
K070051 · DQY
Acumen Medical, Inc.
Cardiovascular · 92d
Cleared Apr 05, 2007
CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL#...
K070680 · NQH
Cardiomems, Inc.
Cardiovascular · 24d
Cleared Mar 29, 2007
ARGON CONTINUOUS FLUSH DEVICE
K070384 · KRA
Argon Medical Devices, Inc.
Cardiovascular · 48d
Cleared Mar 29, 2007
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
K063076 · OWQ
Ascent Healthcare Solutions
Cardiovascular · 174d
Cleared Mar 28, 2007
MODIFICATION TO HEALTH BUDDY APPLIANCE
K070543 · DRG
Health Hero Network, Inc.
Cardiovascular · 30d
Cleared Mar 28, 2007
TR BAND
K070423 · DXC
Terumo Medical Corp.
Cardiovascular · 43d
Cleared Mar 27, 2007
ECG CABLES, TRUNK AND PATIENT LEAD WIRES
K070232 · DSA
American I.V. Products, Inc.
Cardiovascular · 62d
Cleared Mar 27, 2007
MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY
K063090 · IZQ
Medrad, Inc.
Cardiovascular · 168d
Cleared Mar 27, 2007
MOORLD12-B1 LASER DOPPLER BURNS IMAGER
K060976 · DPT
Moor Instruments, Ltd.
Cardiovascular · 351d
Cleared Mar 23, 2007
LINK TO ACUITY CLINICIAN NOTIFIER
K070204 · MSX
Welch Allyn Protocol, Inc.
Cardiovascular · 60d
Cleared Mar 23, 2007
CARDIOBELT ELECTRODE BELT
K063044 · DRX
Monebo Technologies, Inc.
Cardiovascular · 170d
Cleared Mar 23, 2007
BP 101 DIGITAL BLOOD PRESSURE MONITOR
K062033 · DXN
Kingyield Hongkong Limited
Cardiovascular · 248d
Cleared Mar 22, 2007
BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L
K070485 · DXC
Cardiva Medical, Inc.
Cardiovascular · 30d
Cleared Mar 22, 2007
MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0
K062282 · DPS
Monebo Technologies, Inc.
Cardiovascular · 227d
Cleared Mar 21, 2007
PERFORMER CBP SYSTEM
K070213 · DTQ
Rand S.R.L.
Cardiovascular · 58d
Cleared Mar 20, 2007
PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER)
K070588 · MHX
Philips Medical Systems
Cardiovascular · 19d
Cleared Mar 20, 2007
ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER
K063863 · DXQ
Advantage Medical Cables, Inc.
Cardiovascular · 82d
Cleared Mar 16, 2007
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
K070487 · DXO
Volcano Corporation
Cardiovascular · 24d
Cleared Mar 16, 2007
MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER
K062976 · DSI
Ge Medical Systems Information...
Cardiovascular · 168d