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
1081–1104 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 21, 2023
Intra-Operative Positioning System (IOPS®) (MC-1)
K230309 · DQK
Centerline Biomedical, Inc.
Cardiovascular · 138d
Cleared Jun 21, 2023
Accurate 24 Non-invasive blood pressure monitor
K222658 · DXN
Accurate Meditech, Inc.
Cardiovascular · 292d
Cleared Jun 20, 2023
ScleroSafe™ 150 mm, ScleroSafe™ 350 mm
K231148 · KRA
Vvt Medical , Ltd.
Cardiovascular · 60d
Cleared Jun 16, 2023
Zynex Monitoring System, Model CM-1600
K223217 · DSB
Zynex Medical, Inc.
Cardiovascular · 242d
Cleared Jun 15, 2023
SpassageQ
K230386 · PLB
Spass, Inc.
Cardiovascular · 121d
Cleared Jun 14, 2023
Electronic Blood Pressure Monitor
K223291 · DXN
Shenzhen Pango Medical Electronics...
Cardiovascular · 231d
Cleared Jun 12, 2023
Pounce™ Thrombectomy System
K231022 · QEW
Surmodics,Inc.
Cardiovascular · 63d
Cleared Jun 10, 2023
BMR 1900 PHISIO
K223361 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 219d
Cleared Jun 09, 2023
Auryon Atherectomy System
K230709 · MCW
Eximo Medical, Ltd.
Cardiovascular · 87d
Cleared Jun 09, 2023
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted...
K223865 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 168d
Cleared Jun 08, 2023
Acumen Hypotension Prediction Index (HPI) Algorithm
K230057 · QAQ
Edwards Lifesciences, LLC
Cardiovascular · 150d
Cleared Jun 08, 2023
Ablamap® System
K230008 · DQK
Ablacon, Inc.
Cardiovascular · 156d
Cleared Jun 08, 2023
AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
K223918 · DQK
Philips Medical Systems Nederland B.V.
Cardiovascular · 161d
Cleared Jun 07, 2023
HyperVue™ Imaging System
K230691 · NQQ
Spectrawave, Inc.
Cardiovascular · 86d
Cleared Jun 06, 2023
Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter
K230584 · OWQ
Vein 360, LLC
Cardiovascular · 96d
Cleared Jun 06, 2023
Pantheris LV Atherectomy Catheter
K230005 · MCW
Avinger, Inc.
Cardiovascular · 154d
Cleared Jun 06, 2023
ARC Intensive Care Information System (ARC System)
K220117 · MWI
Ordinatrum Solutions
Cardiovascular · 508d
Cleared Jun 02, 2023
CPS Direct™ Universal slittable outer guide catheter (DS2C029)
K231311 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared Jun 02, 2023
Huma RPM (RPM)
K230214 · MWI
Medopad, Inc.
Cardiovascular · 127d
Cleared Jun 01, 2023
Drakon™ and Sequre® Microcatheters
K231293 · DQO
Accurate Medical Therapeutics
Cardiovascular · 28d
Cleared Jun 01, 2023
Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna...
K223929 · QEW
Innova Vascular, Inc.
Cardiovascular · 153d
Cleared CT Jun 01, 2023
Radius VSM and Accessories
K223498 · MHX
Masimo Corporation
Cardiovascular · 192d
Cleared May 31, 2023
Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable...
K221067 · NLH
Surgical Instrument Service and...
Cardiovascular · 414d
Cleared May 30, 2023
RFP-100A Connector Cable (Single Use)
K230571 · DSA
Baylis Medical Technologies, Inc.
Cardiovascular · 90d