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
793–816 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 22, 2024
Fogarty Arterial Embolectomy Catheter with Gate Valve
K233820 · DXE
Edwards Lifesciences
Cardiovascular · 173d
Cleared May 22, 2024
Fogarty Venous Thrombectomy Catheters
K233819 · DXE
Edwards Lifesciences, LLC
Cardiovascular · 173d
Cleared May 22, 2024
Impress Angiographic Catheter
K233268 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 236d
Cleared May 20, 2024
Fogarty Corkscrew Catheters
K233619 · DXE
Edwards Lifesciences
Cardiovascular · 189d
Cleared May 17, 2024
SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
K241042 · DRC
Pressure Products Medical Device...
Cardiovascular · 30d
Cleared May 15, 2024
MVR™ Venous Reservoir Bag 800 mL
K241053 · DTN
Medtronic Cardiac Surgery
Cardiovascular · 28d
Cleared May 14, 2024
Aventus Clot Management System
K240426 · CAC
Inquis Medical
Cardiovascular · 91d
Cleared May 14, 2024
BNLE Hydrophilic Jacketed Peripheral Guidewire
K232662 · DQX
Biomerics Nle
Cardiovascular · 257d
Cleared May 09, 2024
Biofourmis Everion+ (G2)
K233418 · MSX
Biofourmis Singapore Pte., Ltd.
Cardiovascular · 212d
Cleared May 07, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6...
K240954 · PPN
Shockwave Medical, Inc.
Cardiovascular · 29d
Cleared May 07, 2024
LIFEPAK® ECG Cables
K240377 · DSA
Stryker Physio-Control
Cardiovascular · 90d
Cleared May 07, 2024
ASSURE Wearable ECG
K233864 · MWJ
Kestra Medical Technologies, Inc.
Cardiovascular · 153d
Cleared May 03, 2024
Masimo Stork
K234021 · QYU
Masimo Corporation
Cardiovascular · 135d
Cleared May 02, 2024
Siege Vascular Plug (SVP2.5-0.021)
K240261 · KRD
Merit Medical Systems, Inc.
Cardiovascular · 92d
Cleared May 02, 2024
CSF-4 (CSF-4)
K232445 · DPS
Cardiacsense
Cardiovascular · 262d
Cleared May 01, 2024
HOTWIRE™ RF Guidewire
K240900 · DXF
Atraverse Medical
Cardiovascular · 30d
Cleared May 01, 2024
AuST Steerable Sheath
K240829 · DYB
CenterPoint Systems, LLC
Cardiovascular · 36d
Cleared Apr 30, 2024
LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical...
K240156 · DSA
Physio-Control, Inc.
Cardiovascular · 102d
Cleared Apr 29, 2024
XTRA Autotransfusion System (with XTRA Bowl sets)
K240584 · CAC
Sorin Group Italia S.R.L.
Cardiovascular · 59d
Cleared Apr 29, 2024
Blood Pressure Monitor (TMB-2287-B)
K240102 · DXN
Guangdong Transtek Medical...
Cardiovascular · 104d
Cleared Apr 26, 2024
TME Temporary Myocardial Electrode
K232261 · LDF
Osypka AG
Cardiovascular · 270d
Cleared Apr 25, 2024
CDI OneView Monitoring System
K234065 · DRY
Terumo Cardiovascular Systems...
Cardiovascular · 125d
Cleared Apr 25, 2024
Portrait VSM
K233810 · MWI
Ge Medical Systems Information...
Cardiovascular · 147d
Cleared Apr 23, 2024
Provisio™ SLT IVUS™ System
K233948 · OBJ
Provisio Medical, Inc.
Cardiovascular · 131d