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
49–72 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 18, 2026
Triever Duo Catheter
K253419 · QEW
Inari Medical, Inc.
Cardiovascular · 352d
Cleared Sep 18, 2026
Hyperdrive 35 Guidewire
K253146 · DQX
Rapid Medical , Ltd.
Cardiovascular · 358d
Cleared Sep 17, 2026
EnSite™ X EP System
K261729 · DQK
Abbott Medical
Cardiovascular · 114d
Cleared Sep 17, 2026
Vessel Closure Device (VCD177213P)
K260677 · FZP
Vcd Medical S.R.L.
Cardiovascular · 199d
Cleared Sep 16, 2026
X°Port Heart Preservation System
K261913 · MSB
Traferox Technologies, Inc.
Cardiovascular · 100d
Cleared Sep 16, 2026
JADE SCORE PTA Scoring Balloon Dilatation Catheter
K261778 · PNO
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 110d
Cleared Sep 16, 2026
NC PTA Balloon Dilatation Catheter
K254212 · LIT
Kossel Medtech (Suzhou) Co., Ltd.
Cardiovascular · 261d
Cleared Sep 14, 2026
HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)
K261438 · DTZ
Eurosets S.R.L
Cardiovascular · 137d
Cleared Sep 12, 2026
Digistat Care
K261287 · MSX
Ascom Ums Srl Unipersonale
Cardiovascular · 145d
Cleared Sep 11, 2026
Sequential Circulator (SC-4004-DL, SC-4008-DL)
K261807 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 102d
Cleared Sep 11, 2026
ZBPro Diagnostic (Version 2.0)
K261580 · MLO
Zbeats, Inc.
Cardiovascular · 121d
Cleared Sep 11, 2026
Wearable ECG Recorder (YMHeart XY-12)
K254119 · MWJ
Shenzhen Xinyan Medical Technology...
Cardiovascular · 266d
Cleared Sep 11, 2026
Extroducer Infusion Catheter System
K254051 · KRA
SmartWise Sweden AB
Cardiovascular · 268d
Cleared Sep 10, 2026
Upper Arm Blood pressure monitor (BP7155D)
K261929 · DXN
Omron Healthcare, Inc.
Cardiovascular · 93d
Cleared Sep 10, 2026
ACUNAV Luxera 4D ICE Catheter
K261696 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 111d
Cleared Sep 10, 2026
TruPress
K254074 · DRS
Procerus Enterprises
Cardiovascular · 266d
Cleared CT Sep 08, 2026
Emboliner Embolic Protection System (EPC-03)
K261715 · PUM
Emboline, Inc.
Cardiovascular · 109d
Cleared Sep 04, 2026
Digital Indeflator INFLANTE
K260035 · MAV
UAB Telemedicina
Cardiovascular · 241d
Cleared Sep 04, 2026
Peerbridge COR MDx (Cor MDx)
K253529 · MWJ
Peerbridge Health, Inc.
Cardiovascular · 295d
Cleared Sep 03, 2026
Helo Max Thrombectomy System (HEL2090)
K261800 · QEW
Endovascular Engineering
Cardiovascular · 94d
Cleared Sep 03, 2026
CROSSLEAD Standard 035 and CROSSLEAD Stiff 035
K261281 · DQX
Filmecc Co., Ltd.
Cardiovascular · 139d
Cleared Sep 03, 2026
Mayumi™ Thrombectomy System
K254035 · QEZ
MicroVention, Inc., d/b/a Terumo Neuro
Cardiovascular · 261d
Cleared Sep 03, 2026
Happy Health Blood Pressure Monitor
K254000 · DXN
Happy Health, Inc.
Cardiovascular · 262d
Cleared Sep 01, 2026
Carescape ONE
K260656 · MHX
GE Healthcare Finland Oy
Cardiovascular · 186d