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
3817–3840 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 09, 2014
ITCLAMP 50
K140805 · DXC
Innovative Trauma Care, Inc.
Cardiovascular · 191d
Cleared Oct 09, 2014
FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
K132592 · DYB
Cook, Inc.
Cardiovascular · 416d
Cleared Oct 08, 2014
IDC INTERLOCKING DETACHABLE COIL
K141378 · KRD
Boston Scientific Corporation
Cardiovascular · 134d
Cleared Oct 08, 2014
A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR
K141201 · DXN
A & D Co., Ltd.
Cardiovascular · 152d
Cleared Oct 07, 2014
A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR
K141160 · DXN
A & D Co., Ltd.
Cardiovascular · 155d
Cleared Sep 30, 2014
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K141547 · DQY
Reflow Medical
Cardiovascular · 111d
Cleared Sep 26, 2014
SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE
K141113 · DXN
Spacelabs Healthcare, Ltd.
Cardiovascular · 149d
Cleared Sep 25, 2014
TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
K142546 · DRE
Spectranetics, Inc.
Cardiovascular · 15d
Cleared Sep 25, 2014
PTA BALLOON DILATATION CATHETER
K141150 · LIT
Boston Scientific Corp
Cardiovascular · 143d
Cleared Sep 24, 2014
Ultraverse 035 PTA Balloon Dilatation Catheter
K142261 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 41d
Cleared Sep 19, 2014
SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS
K141998 · DXQ
Pinghu Sama Medical Packing Co., Ltd.
Cardiovascular · 58d
Cleared Sep 19, 2014
ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER
K141453 · DQO
Lightlab Imaging, Inc.
Cardiovascular · 109d
Cleared Sep 19, 2014
APOLLO BALLOON DILATATION CATHETER
K133852 · LOX
Brosmed Medical
Cardiovascular · 274d
Cleared Sep 19, 2014
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR
K133753 · QYX
Infobionic, Inc.
Cardiovascular · 284d
Cleared Sep 18, 2014
TRUE BA V BALLOON VALVULOPLASTY CATHETER
K141985 · OZT
C.R. Bard, Inc.
Cardiovascular · 58d
Cleared Sep 18, 2014
EDWARDS ESHEATH INTRODUCER SET
K141696 · DYB
Edwards Lifesciences
Cardiovascular · 86d
Cleared Sep 18, 2014
MIVI 6F GUIDE CATHETER
K140557 · DQY
Mivi, LLC
Cardiovascular · 197d
Cleared Sep 17, 2014
Arrow GPSCath Balloon Dialation Catheter (150 cm)
K142300 · LIT
Hotspur Technologies, Inc.,
Cardiovascular · 30d
Cleared Sep 17, 2014
TRANSONIC HCM 103 SYSTEM
K134035 · DXG
Transonic Systems, Inc.
Cardiovascular · 260d
Cleared Sep 16, 2014
TRANSONIC HCM 102 SYSTEM
K140017 · DXG
Transonic Systems, Inc.
Cardiovascular · 257d
Cleared Sep 15, 2014
ABPM7100
K140928 · DXN
I.E.M. GmbH
Cardiovascular · 157d
Cleared Sep 12, 2014
ARTIMES BALLOON DILATATION CATHETER
K141025 · LOX
Brosmed Medical
Cardiovascular · 144d
Cleared Sep 12, 2014
MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE
K140608 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 186d
Cleared Sep 12, 2014
INTRA. OX HANDHELD TISSUE OXIMETER
K133983 · MUD
Vioptix, Inc.
Cardiovascular · 259d