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
121–144 of 18,182
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 CT Jun 18, 2026
ZywieZ3 Sensor & Adhesive
K252839 · MWJ
Zywie, Inc.
Cardiovascular · 286d