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
1705–1728 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 22, 2021
Piccolo Medical SmartPICC System
K200037 · LJS
Piccolo Medical, Inc.
Cardiovascular · 380d
Cleared Jan 21, 2021
Overlapped Compression Therapy
K202839 · JOW
Jkh Health Co., Ltd.
Cardiovascular · 118d
Cleared Jan 19, 2021
ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
K203726 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 29d
Cleared Jan 19, 2021
IntraSight Mobile
K203719 · IYO
Volcano Corporation
Cardiovascular · 29d
Cleared Jan 15, 2021
Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
K202141 · DYB
Argon Medical Devices, Inc.
Cardiovascular · 168d
Cleared Jan 15, 2021
NeVa PV Thrombectomy Device
K201085 · QEW
Vesalio
Cardiovascular · 267d
Cleared Jan 11, 2021
Switched Internal Paddles
K203231 · LDD
Philips North America, LLC
Cardiovascular · 70d
Cleared Jan 09, 2021
CLEWICU System (ClewICUServer and ClewICUnitor)
K200717 · QNL
Clew Medical , Ltd.
Cardiovascular · 297d
Cleared Jan 08, 2021
HeartFlow Analysis
K203329 · PJA
HeartFlow, Inc.
Cardiovascular · 57d
Cleared Jan 07, 2021
BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision...
K202405 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 139d
Cleared Jan 06, 2021
Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood...
K203652 · DXQ
Jkh USA, LLC
Cardiovascular · 23d
Cleared Jan 06, 2021
InBody
K200560 · DXN
Inbody Co., Ltd.
Cardiovascular · 308d
Cleared Jan 05, 2021
Bidop 7
K201114 · DPW
Koven Technology, Inc.
Cardiovascular · 253d
Cleared Jan 05, 2021
Halo Single-Loop Microsnare Kit
K200963 · MMX
Argon Medical Devices, Inc.
Cardiovascular · 270d
Cleared Dec 30, 2020
Upper Arm Electronic Blood Pressure Monitor
K202372 · DXN
Conmo Electronic Company Limited
Cardiovascular · 133d
Cleared Dec 29, 2020
M5 Recorder
K202456 · DSH
Global Instrumentation, LLC
Cardiovascular · 124d
Cleared Dec 23, 2020
Bridge Occlusion Balloon
K203540 · MJN
Spectranetics, Inc.
Cardiovascular · 20d
Cleared Dec 22, 2020
CAPERE Thrombectomy System
K203476 · QEW
Vascular Medcure, Inc.
Cardiovascular · 27d
Cleared Dec 22, 2020
Serranator PTA Serration Balloon Catheter
K203437 · PNO
Cagent Vascular, LLC
Cardiovascular · 29d
Cleared Dec 22, 2020
ReVene Thrombectomy Catheter
K201705 · QEW
Vetex Medical, Ltd.
Cardiovascular · 183d
Cleared Dec 22, 2020
Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal...
K201489 · DYB
Argon Medical Devices, Inc.
Cardiovascular · 201d
Cleared Dec 20, 2020
Flexitouch Plus System
K203178 · JOW
Tactile Systems Technology, Inc. (Dba...
Cardiovascular · 55d
Cleared Dec 18, 2020
FlowTriever Retrieval/Aspiration System
K202345 · QEW
Inari Medical
Cardiovascular · 122d
Cleared Dec 17, 2020
AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter
K201081 · DQK
Philips Medical System Nederland B.V.
Cardiovascular · 239d