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
97–120 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 21, 2026
PanopticAI Vital Signs (1.6.1-22)
K260066 · QME
PanopticAI technologies Limited
Cardiovascular · 132d
Cleared May 20, 2026
The Circadia C300 System (C300)
K261286 · DRT
Circadia Health, Inc.
Cardiovascular · 30d
Cleared May 20, 2026
WAVE PTA Balloon Catheter
K260304 · LIT
WAVE Medical AG
Cardiovascular · 110d
Cleared May 20, 2026
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM...
K260098 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 127d
Cleared May 20, 2026
Blood Pressure Monitor (W06LT)
K253570 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 184d
Cleared May 15, 2026
TruSelect™ 2.6 Microcatheter
K260771 · KRA
Boston Scientific Corporation
Cardiovascular · 67d
Cleared May 14, 2026
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M,...
K254048 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 148d
Cleared May 06, 2026
YP-710T Series NIBP Cuff
K260747 · DXQ
Nihon Kohden Corporation
Cardiovascular · 61d
Cleared May 06, 2026
KardiaPSI Balloon Catheter
K253855 · OZT
Intervention Tech, Inc. ; dba Corvention
Cardiovascular · 154d
Cleared May 06, 2026
BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
K253152 · DXN
Biozen, LLC
Cardiovascular · 222d
Cleared May 01, 2026
BIOMONITOR IV (471155)
K261074 · MXD
Biotronik, Inc.
Cardiovascular · 30d
Cleared Apr 30, 2026
c-med0 alpha
K253436 · MWI
Cosinuss GmbH
Cardiovascular · 211d
Cleared Apr 29, 2026
Echo Large Bore Introducer Sheath
K260606 · DYB
Echo Medical, LLC
Cardiovascular · 64d
Cleared Apr 28, 2026
Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581,...
K260260 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 90d
Cleared Apr 28, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B,...
K252501 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 263d
Cleared Apr 27, 2026
Fusion Bioline Vascular Graft
K252445 · DSY
Maquet Cardiovascular, LLC
Cardiovascular · 266d
Cleared Apr 24, 2026
Amplatzer TorqVue Delivery System
K260993 · DQY
Abbott
Cardiovascular · 29d
Cleared Apr 24, 2026
INDIGO® Aspiration System – INDIGO Link
K260599 · QEW
Penumbra, Inc.
Cardiovascular · 59d
Cleared Apr 24, 2026
OPTIS Mobile Next Imaging System (1014932)
K253459 · NQQ
Abbott Medical
Cardiovascular · 199d
Cleared Apr 24, 2026
FloPatch FP120
K252810 · DPW
Flosonics Medical
Cardiovascular · 233d
Cleared Apr 24, 2026
Vista CMS
K250349 · MHX
Shanghai Draeger Medical Instrument...
Cardiovascular · 441d
Cleared Apr 24, 2026
Compression Therapy Device (LGT-2202DVT)
K250242 · JOW
Guangzhou Longest Medical Technology...
Cardiovascular · 452d
Cleared Apr 23, 2026
OptiMap Catheter - 60mm (OPTI-CATH2-60)
K261012 · MTD
Cortex, Inc.
Cardiovascular · 27d
Cleared Apr 23, 2026
Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae
K260195 · DWF
Medtronic, Inc.
Cardiovascular · 91d