Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,182 results
1417–1440 of 18,182
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 CT 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