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
313–336 of 18,110
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 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 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 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 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