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
49–72 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 09, 2026
UbiqVue™ 2AYe Cardiac System (UX2253)
K261569 · DRG
Lifesignals, Inc.
Cardiovascular · 58d
Cleared Jul 09, 2026
LifeLens Physiological Monitor
K260157 · DSH
LifeLens Technologies, Inc.
Cardiovascular · 170d
Cleared Jul 09, 2026
ScioCardio ECG Analysis Platform
K252978 · DQK
Synergen Technology Labs, LLC
Cardiovascular · 295d
Cleared Jul 08, 2026
BlueDop Vascular Expert
K260700 · DPW
BlueDop Medical, Ltd.
Cardiovascular · 126d
Cleared Jul 08, 2026
ThermAffyx(TM) Patient Safety System
K260278 · DWJ
Stihler Electronic GmbH
Cardiovascular · 160d
Cleared Jul 06, 2026
Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/...
K261529 · DYB
Hartman Medical Group, LLC
Cardiovascular · 59d
Cleared Jul 02, 2026
Amplatzer TorqVue LP Delivery System
K261825 · DQY
Abbott
Cardiovascular · 30d
Cleared Jul 02, 2026
ILR ECG Analyzer (IM007)
K253463 · DQK
Implicity, Inc.
Cardiovascular · 267d
Cleared Jul 02, 2026
SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
K252463 · DPS
Edan Instruments, Inc.
Cardiovascular · 330d
Cleared Jun 26, 2026
LightningWire Transseptal Puncture System (TPS)
K261745 · DXF
ElectroWire Medical
Cardiovascular · 30d
Cleared Jun 26, 2026
Arterial Pressure Monitoring Set/Tray
K261455 · DQO
Spectrum Vascular
Cardiovascular · 56d
Cleared Jun 26, 2026
ECLIPTIS Left Atrial Appendage Exclusion System (ECS135)
K254232 · PZX
Edwards Lifesciences
Cardiovascular · 179d
Cleared Jun 26, 2026
BioTracker 2.0
K253306
Biotracker, LLC
Cardiovascular · 270d
Cleared Jun 25, 2026
SimplGuide
K261242 · DYB
Pendracare
Cardiovascular · 71d
Cleared Jun 25, 2026
DVT Garment
K253386 · JOW
Vistar Medical Supplies Co., Ltd.
Cardiovascular · 268d
Cleared Jun 25, 2026
mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML,...
K253384 · MWJ
Seers Technology Co., Ltd.
Cardiovascular · 268d
Cleared Jun 24, 2026
Concerto Versa™ Detachable Coil
K261866 · KRD
Medtronic, Inc.
Cardiovascular · 20d
Cleared Jun 24, 2026
CLEAR™ Aspiration System
K253404
Insera Therapeutics, Inc.
Cardiovascular · 267d
Cleared Jun 22, 2026
Health Line Tearaway Introducer
K261950 · DYB
Health Line International Corporation
Cardiovascular · 12d
Cleared Jun 22, 2026
Medline Reusable Blood Pressure Cuff
K254287 · DXQ
Medline Industries, LP
Cardiovascular · 173d
Cleared Jun 18, 2026
MEMO 4D Curve™ Semirigid mitral annuloplasty ring
K261707 · KRH
Corcym S.r.l.
Cardiovascular · 27d
Cleared Jun 18, 2026
SmartSpectra Vital Signs Monitor 1.0
K254169 · QME
Presage Security, Inc. d/b/a Presage...
Cardiovascular · 177d
Cleared Jun 18, 2026
Wrist Blood Pressure Monitor (XW-05)
K253126 · DXN
Shenzhen Ziqing Medical Equipment...
Cardiovascular · 266d
Cleared Jun 18, 2026
ZywieZ3 Sensor & Adhesive
K252839 · MWJ
Zywie, Inc.
Cardiovascular · 286d