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
385–408 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 30, 2025
Biopsy Forceps
K252722 · DWZ
Fehling Instruments GmbH
Cardiovascular · 33d
Cleared Sep 30, 2025
IBP transducer adapter cable, Argon/BD/Ohmeda, 2m
K251669 · DSA
Shanghai Draeger Medical Instrument...
Cardiovascular · 123d
Cleared Sep 30, 2025
TigerConnect Alarm Management
K243270 · MSX
Tigerconnect
Cardiovascular · 349d
Cleared Sep 29, 2025
Primero Safe Access System
K252441 · DYB
South53, LLC
Cardiovascular · 56d
Cleared CT Sep 26, 2025
VitalStream ART Connect
K251275 · DXG
Caretaker Medical
Cardiovascular · 155d
Cleared Sep 25, 2025
EnSite™ X EP System
K252013 · DQK
Abbott Medical
Cardiovascular · 90d
Cleared Sep 24, 2025
Pounce(TM) Sheath
K252227 · DYB
Surmodics,Inc.
Cardiovascular · 70d
Cleared Sep 23, 2025
Edwards MC3 Tricuspid annuloplasty ring (4900)
K251982 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared CT Sep 22, 2025
Santreva™-ATK Endovascular Revasculariztion Catheter
K252315 · PDU
AngioSafe, Inc.
Cardiovascular · 59d
Cleared Sep 19, 2025
Bunkerhill ECG-EF
K250649 · QYE
BunkerHill Health
Cardiovascular · 199d
Cleared Sep 17, 2025
Carpentier-Edwards Physio Annuloplasty Ring (4450)
K251688 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 107d
Cleared Sep 17, 2025
PlasmaFlow X Compression Sleeve Device (XPF0001)
K251446 · JOW
Manamed, LLC
Cardiovascular · 131d
Cleared Sep 17, 2025
Assert-IQ (DM5000)
K251221 · MXD
Abbott
Cardiovascular · 149d
Cleared Sep 12, 2025
Stethophone Pro
K252595 · DQD
Sparrow Acoustics, Inc.
Cardiovascular · 28d
Cleared Sep 12, 2025
LUX-Dx II Insertable Cardiac Monitor (M302)
K252593 · MXD
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Sep 12, 2025
Vertex(TM) Catheter
K252027 · DYB
Jupiter Endovascular
Cardiovascular · 74d
Cleared Sep 12, 2025
Volta AF-Xplorer II
K251518 · DQK
Volta Medical
Cardiovascular · 119d
Cleared Sep 11, 2025
PowerWire® 14 Radiofrequency Guidewire Kit
K251158 · PDU
Baylis Medical Technologies, Inc.
Cardiovascular · 149d
Cleared Sep 11, 2025
Hypertension Notification Feature (HTNF)
K250507 · SFR
Apple, Inc.
Cardiovascular · 202d
Cleared CT Sep 10, 2025
Surfacer Inside-Out Access Catheter System
K252527 · QJH
Merit Medical System, Inc.
Cardiovascular · 30d
Cleared Sep 09, 2025
Edema Guard Monitor (EGM) CardioSet-001
K250922 · DSB
Cardioset Medical , Ltd.
Cardiovascular · 166d
Cleared Sep 09, 2025
PhotonBlade 3
K250483 · GEI
Stryker Instruments
Cardiovascular · 202d
Cleared CT Sep 05, 2025
pREBOA-PRO Catheter
K243795 · MJN
Prytime Medical Devices, Inc.
Cardiovascular · 269d
Cleared Sep 04, 2025
EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01)
K251463 · DQK
Abbott Medical
Cardiovascular · 115d