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
7609–7632 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 10, 2004
NUMED PTS X SIZING BALLOON CATHETER
K041306 · MJN
NuMED, Inc.
Cardiovascular · 24d
Cleared Jun 08, 2004
POISE DATAENGINE
K040969 · MWI
Poise Technology Corporation
Cardiovascular · 55d
Cleared Jun 07, 2004
QUANTIX OR VESSEL STABILIZER DEVICE
K041180 · DPW
Cardiosonix, Ltd.
Cardiovascular · 32d
Cleared Jun 07, 2004
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
K041281 · DSP
Datascope Corp.
Cardiovascular · 25d
Cleared Jun 04, 2004
MODIFICATION TO UNITY NETWORK ID
K040559 · MWI
Ge Medical Systems Information...
Cardiovascular · 93d
Cleared Jun 04, 2004
SENSILASE PAD 3000
K040654 · DPW
Optical Sensors, Inc.
Cardiovascular · 84d
Cleared Jun 04, 2004
PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS
K041235 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 24d
Cleared Jun 04, 2004
MODIFICATION TO M2376A DEVICELINK SYSTEM
K041401 · MWI
Philips Medical Systems
Cardiovascular · 9d
Cleared Jun 03, 2004
FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM
K033711 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 190d
Cleared Jun 03, 2004
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K040458 · MHX
Ge Medical Systems Information...
Cardiovascular · 101d
Cleared Jun 02, 2004
MODIFICATION TO CAREMATIX WELLNESS SYSTEM
K040966 · DRG
Carematix, Inc.
Cardiovascular · 49d
Cleared Jun 02, 2004
COMBOMAP PRESSURE AND FLOW SYSTEM
K041134 · OBJ
Volcano Therapeutics, Inc.
Cardiovascular · 33d
Cleared Jun 01, 2004
CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL,...
K033048 · MHX
Cas Medical Systems, Inc.
Cardiovascular · 246d
Cleared Jun 01, 2004
CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES
K040395 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 105d
Cleared Jun 01, 2004
COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM
K040615 · DXC
Advanced Vascular Dynamics
Cardiovascular · 84d
Cleared Jun 01, 2004
MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM
K040713 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 75d
Cleared Jun 01, 2004
EXPORT CATHETER
K040869 · QEZ
Medtronic Vascular
Cardiovascular · 60d
Cleared May 28, 2004
MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130
K040552 · DYB
Cryocor, Inc.
Cardiovascular · 87d
Cleared May 26, 2004
ZARGIS ACOUSTIC CARDIOSCAN
K031517 · DQD
Zargis Medical Corp.
Cardiovascular · 377d
Cleared May 26, 2004
FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR
K040246 · MHX
Fukuda Denshi USA, Inc.
Cardiovascular · 113d
Cleared May 25, 2004
JMS BYPASS TUBE
K032977 · DWF
Jms North America Corp.
Cardiovascular · 244d
Cleared May 25, 2004
TRANSXCHANGE SUPPORT CATHETER
K033540 · DQY
Medtronic Vascular
Cardiovascular · 197d
Cleared May 25, 2004
SMARTLANK WIRELESS, MODEL 001970
K033642 · MKJ
Mrl, A Welch Allyn Company
Cardiovascular · 187d
Cleared May 25, 2004
HEARTSINE SAMARITAN PAD
K041067 · MKJ
Heartsine Technologies, Inc.
Cardiovascular · 32d