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
1777–1800 of 18,182
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