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
1–24 of 18,110
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 Aug 04, 2026
Vertex™ Thrombectomy System
K261523 · QEW
Jupiter Endovascular
Cardiovascular · 89d