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
1009–1032 of 18,110
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 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