12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TriVerse Total Knee Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·00852417003118·Bronchial Challenge Kit, Disposable (single pat...
SetX 13mmX12mm Cervical Rasp 8mm, 9mm, 10mm
FDA UDI
XENCO MEDICAL LLC·B064XM12223801·
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044204759·TEST TUBE 17X100MM
OCELOT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
LIVESIRE ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 16, 2024
SYN POR PLUS HA SO STEM SZ 11
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code LPH·November 4, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·August 25, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code ITI·July 12, 2013
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 23, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025