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
73–96 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 28, 2026
LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
K262735 · MXD
Medtronic, Inc.
Cardiovascular · 28d
Cleared Aug 28, 2026
Kiba CTO Crossing Catheter
K262013 · PDU
Reflow Medical, Inc.
Cardiovascular · 74d
Cleared Aug 28, 2026
Carescape Canvas 1000
K260343 · MHX
GE Healthcare Finland Oy
Cardiovascular · 207d
Cleared Aug 27, 2026
GenesisX RMN
K262744 · DXX
Stereotaxis, Inc.
Cardiovascular · 24d
Cleared Aug 26, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus,...
K261394 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 119d
Cleared Aug 24, 2026
SEISMIQ™ Intravascular Lithotripsy System
K260246 · PPN
Bolt Medical, Inc.
Cardiovascular · 209d
Cleared Aug 21, 2026
Artix™ MT
K262538 · QEW
Inari Medical, Inc.
Cardiovascular · 29d
Cleared Aug 21, 2026
Disposable Warming Blanket
K262089 · DWJ
Hangzhou Tappa Medical Technology...
Cardiovascular · 60d
Cleared Aug 21, 2026
Affera Integrated Mapping System
K262005 · DQK
Medtronic, Inc.
Cardiovascular · 67d
Cleared Aug 21, 2026
Tempus ECG-PH
K253699 · SAT
Tempus AI, Inc.
Cardiovascular · 270d
Cleared Aug 21, 2026
AVVIGO™+ Multi-Modality Guidance System
K253692 · DQK
Boston Scientific
Cardiovascular · 273d
Cleared Aug 20, 2026
Infinity® Acute Care System (IACS) – VG8.1
K260579 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 181d
Cleared Aug 14, 2026
NC Euphora Rapid Exchange Balloon Dilatation Catheter
K261428 · LOX
Medtronic, Ireland
Cardiovascular · 106d
Cleared Aug 14, 2026
NHanceIT
K260559 · DQY
IMDS Operation B.V.
Cardiovascular · 176d
Cleared Aug 14, 2026
Vital Signs Monitor (CLEO2)
K260438 · MWI
Infinium Medical, Inc.
Cardiovascular · 184d
Cleared Aug 14, 2026
medilogFD
K253562 · MWJ
Schiller AG
Cardiovascular · 270d
Cleared Aug 13, 2026
BP Go (BPP-855)
K261061 · DXN
Wellvii, Inc.
Cardiovascular · 135d
Cleared Aug 13, 2026
Dashboard (P007000)
K260211 · MSX
Hill-Rom, Inc.
Cardiovascular · 202d
Cleared Aug 13, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor...
K253425 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 316d
Cleared Aug 12, 2026
EluPro Antibiotic-Eluting BioEnvelope
K262406 · FTM
Boston Scientific
Cardiovascular · 28d
Cleared Aug 07, 2026
Mistral-Air® Warming System
K261437 · DWJ
The Surgical Company International...
Cardiovascular · 99d
Cleared Aug 06, 2026
Telemetry Monitor (iT30, iT50)
K251508 · MHX
Edan Instruments, Inc.
Cardiovascular · 447d
Cleared Aug 05, 2026
pVasc Net Mechanical Thrombectomy Device
K254211
Vesalio, Inc.
Cardiovascular · 219d
Cleared CT Aug 04, 2026
Vertex™ Thrombectomy System
K261523 · QEW
Jupiter Endovascular
Cardiovascular · 89d