8 results
·
37ms
·
Sources: EU EUDAMED, US FDA
BELTONE PERSONAL HEARING SCREENER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
XLIF
FDA UDI
Nuvasive, Inc.·00887517417268·XLIF Annulus Cutter, 6x16mm Angled
AccuLIF TL and PL Cage
FDA 510(k)
FDA Class 2
·Orthopedic
AVI GUARDIAN 400 INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
FOUNDATION HIP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWA·December 14, 2010
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 5, 2013
ACCESS
FDA Adverse Event
Malfunction
·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·July 18, 2014
Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44
FDA Enforcement
Class II
·Ongoing·Steris Corporation·May 10, 2023