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
289–312 of 18,110
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