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
1345–1368 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 04, 2022
Serranator PTA Serration Balloon Catheter
K220704 · PNO
Cagent Vascular, LLC
Cardiovascular · 55d
Cleared May 04, 2022
Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida...
K212588 · DQY
C.R. Bard, Inc.
Cardiovascular · 261d
Cleared May 04, 2022
LiveOne
K201302 · DXN
Livemetric (Medical) S.A.
Cardiovascular · 719d
Cleared May 03, 2022
ECGenius System
K220306 · DQK
Cath Vision Aps
Cardiovascular · 90d
Cleared Apr 30, 2022
Ultiri Measurement System
K220243 · DQK
Abbott Medical
Cardiovascular · 92d
Cleared Apr 29, 2022
Oxehealth Vital Signs
K220899 · QME
Oxehealth Limited
Cardiovascular · 32d
Cleared Apr 29, 2022
LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)
K220383 · KRD
Okami Medical
Cardiovascular · 78d
Cleared Apr 27, 2022
EXTesia Introducer Sheath Set
K220604 · DYB
Curatia Medical Co.
Cardiovascular · 56d
Cleared Apr 27, 2022
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral...
K220568 · MCW
Cardiovascualr Systems, Inc.
Cardiovascular · 58d
Cleared Apr 26, 2022
AliveCor QT Service
K212662 · DQK
AliveCor, Inc.
Cardiovascular · 246d
Cleared Apr 25, 2022
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
K221041 · PPN
Shockwave Medical, Inc.
Cardiovascular · 17d
Cleared Apr 25, 2022
CER-S
K213861 · DQK
Cardiocalm Srl
Cardiovascular · 136d
Cleared Apr 21, 2022
MESI mTABLET TBI diagnostic system, MESI mTABLET TBI
K213730 · JOM
Mesi, Development of Medical Devices,...
Cardiovascular · 146d
Cleared Apr 20, 2022
EKOS+ Endovascular Device
K220866 · QEY
Boston Scientific
Cardiovascular · 26d
Cleared Apr 19, 2022
Spartan Center Wire
K220075 · DQX
Spartan Micro, Inc.
Cardiovascular · 99d
Cleared Apr 14, 2022
Amputee Garment for use with Lympha Press Optimal Plus
K214053 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 108d
Cleared Apr 14, 2022
Coala Heart Monitor
K212163 · DPS
Coala Life AB
Cardiovascular · 276d
Cleared Apr 13, 2022
Everest 20 Inflation Device and 3-way Stopcock (AC2200)
K220773 · MAV
Medtronic Vascular
Cardiovascular · 28d
Cleared Apr 13, 2022
CARESCAPE B450, E-musb
K213363 · MHX
GE Healthcare Finland Oy
Cardiovascular · 183d
Cleared Apr 13, 2022
Carescape B850, E-musb
K213336 · MHX
GE Healthcare Finland Oy
Cardiovascular · 189d
Cleared Apr 13, 2022
CARESCAPE B650, E-musb
K213181 · MHX
GE Healthcare Finland Oy
Cardiovascular · 196d
Cleared Apr 12, 2022
EMBOLD Fibered Detachable Coil System
K213398 · KRD
Boston Scientific Corporation
Cardiovascular · 176d
Cleared Apr 12, 2022
CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101,...
K213234 · MHX
Ge Medical Systems Information...
Cardiovascular · 194d
Cleared Apr 11, 2022
XO CROSS CORONARY Support Catheter
K214107 · DQY
Transit Scientific, LLC
Cardiovascular · 103d