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
169–192 of 18,182
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 CT 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