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
361–384 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 24, 2025
AngioVac Cannula
K253106 · DWF
AngioDynamics, Inc.
Cardiovascular · 30d
Cleared Oct 24, 2025
LumiGuide Equipment R2.1
K252645 · DQK
Philips Medical Systems Nederland B.V.
Cardiovascular · 64d
Cleared Oct 24, 2025
CoroFlow Cardiovascular System
K252238 · DQK
Coroventis Research AB
Cardiovascular · 99d
Cleared Oct 24, 2025
Arctic Sun Temperature Management System (Model 5000)
K251974 · DWJ
Medivance, Inc.
Cardiovascular · 120d
Cleared Oct 24, 2025
Vesalio Peripheral System
K251312 · QEZ
Vesalio, Inc.
Cardiovascular · 179d
Cleared Oct 23, 2025
PerQseal Introducers
K252309 · DYB
Vivasure Medical Limited
Cardiovascular · 91d
Cleared Oct 22, 2025
Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018,...
K251185 · QEW
Intervene
Cardiovascular · 189d
Cleared Oct 22, 2025
XC11 ICE System, USA
K250955 · OBJ
Yorlabs, Inc.
Cardiovascular · 205d
Cleared Oct 21, 2025
HemoSphere Stream Module
K253034 · DQK
Edwards Lifesciences
Cardiovascular · 29d
Cleared Oct 21, 2025
Introducer Sheath Set
K251838 · DYB
Cardiocycle Medical(Suzhou) Co., Ltd.
Cardiovascular · 127d
Cleared Oct 20, 2025
Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)
K252277 · DSY
Vascular Flow Technologies Limited
Cardiovascular · 90d
Cleared Oct 17, 2025
IntelliVue Patient monitors MX400, MX450, MX500, MX550
K251146 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 186d
Cleared Oct 17, 2025
SureAx-Guide™
K250203 · DQX
Sureax Medical, LLC
Cardiovascular · 266d
Cleared Oct 16, 2025
INDIGO® Aspiration System – Lightning Flash Aspiration Tubing
K252612 · QEW
Penumbra, Inc.
Cardiovascular · 58d
Cleared Oct 16, 2025
Re:Balans
K243727 · DSB
Mode Sensors AS
Cardiovascular · 317d
Cleared Oct 15, 2025
Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature...
K250979 · NZE
Zoll Circulation, Inc.
Cardiovascular · 198d
Cleared Oct 14, 2025
LIFEPAK 15 AC Power Adapter (41577-000333)
K253099 · MPD
Physio-Control, Inc.
Cardiovascular · 20d
Cleared Oct 09, 2025
Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)
K251795 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 119d
Cleared Oct 08, 2025
14Fr Low Profile Introducer Kit
K252766 · DYB
Abiomed, Inc.
Cardiovascular · 40d
Cleared Oct 03, 2025
Amplatzer Guidewire
K250031 · DQX
Abbott Medical
Cardiovascular · 269d
Cleared Oct 02, 2025
Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125,...
K252769 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 30d
Cleared Oct 02, 2025
EasyTeleMed (2.0.2)
K252440 · DRG
Ingeniars S.R.L.
Cardiovascular · 59d
Cleared Oct 02, 2025
CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and...
K252059 · OHA
Artivion, Inc.
Cardiovascular · 93d
Cleared Oct 01, 2025
Vena MicroAngioscope™ System
K251767 · LYK
Vena Medical Holdings Corp
Cardiovascular · 113d