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
2713–2736 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 03, 2017
Fixed Patient Leads ECG Cable (Model 3153)
K172591 · DSA
Boston Scientific Corporation
Cardiovascular · 66d
Cleared Nov 03, 2017
Phlebo Press DVT Model
K172277 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 98d
Cleared Nov 03, 2017
Reprocessed Halo XP Diagnostic Electrophysiology Catheter
K171788 · NLH
Innovative Health, LLC
Cardiovascular · 141d
Cleared Nov 02, 2017
myMerlin(TM) Mobile Application Model APP1001
K173232 · MXC
St Jude Medical
Cardiovascular · 29d
Cleared Nov 02, 2017
VitalPatch® VitalConnect Platform
K163453 · DRG
Vitalconnect, Inc.
Cardiovascular · 328d
Cleared Nov 01, 2017
Monitor B125, Monitor B105
K171580 · MHX
Ge Medical Systems China Co., Ltd.
Cardiovascular · 154d
Cleared Oct 30, 2017
Stethee Pro
K172296 · DQD
M3Dicine Pty , Ltd.
Cardiovascular · 91d
Cleared Oct 30, 2017
Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging...
K172236 · MCW
Avinger, Inc.
Cardiovascular · 97d
Cleared Oct 27, 2017
Tubing Pack
K171979 · DWF
Medtronic, Inc.
Cardiovascular · 119d
Cleared Oct 27, 2017
Automatic Blood Pressure Monitor Model LD-518 & LD-537
K170466 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 254d
Cleared Oct 25, 2017
Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion...
K172626 · DTZ
Medtronic, Inc.
Cardiovascular · 54d
Cleared Oct 25, 2017
3880 MRI Patient Monitoring System
K172200 · MWI
Iradimed Corporation
Cardiovascular · 96d
Cleared Oct 25, 2017
Gel-Bead
K171946 · KRD
Vascular Solutions, Inc.
Cardiovascular · 118d
Cleared Oct 25, 2017
Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U
K170454 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 252d
Cleared Oct 24, 2017
ClearLumen II Peripheral Thrombectomy System
K172000 · QEZ
Walk Vascular, LLC
Cardiovascular · 113d
Cleared Oct 24, 2017
SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot...
K171751 · MWI
Capsule Technologie Sas
Cardiovascular · 133d
Cleared Oct 23, 2017
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
K173063 · OBJ
Acist Medical Systems, Inc.
Cardiovascular · 24d
Cleared Oct 23, 2017
TruWave Disposable Pressure Transducer
K171996 · DXO
Edwards Lifesciences, LLC
Cardiovascular · 112d
Cleared Oct 23, 2017
Reprocessed Inquiry Steerable Diagnostic EP Catheter
K171277 · DRF
Innovative Health, LLC
Cardiovascular · 175d
Cleared Oct 20, 2017
Heraeus TMW Guidewire
K173052 · DQX
Heraeus Medical Components, LLC
Cardiovascular · 22d
Cleared Oct 20, 2017
GuideLiner V3 Catheter
K172090 · DQY
Vascular Solutions, Inc.
Cardiovascular · 101d
Cleared Oct 20, 2017
D'Vill Introducer
K171206 · DYB
NuMED, Inc.
Cardiovascular · 178d
Cleared Oct 20, 2017
SafeSept Transseptal Guidewire
K170671 · DRC
Pressure Products Medical Device...
Cardiovascular · 228d
Cleared Oct 19, 2017
065 Zenith, 074 Zenith
K171672 · DQY
Inneuroco, Inc.
Cardiovascular · 135d