10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Bloomlife MFM-Pro
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Philips
FDA UDI
Sbo Hearing A/S·05714464011070·HEARLINK 5030 MNR T R BE
HEALIX ADVANCE
FDA UDI
Medos International Sàrl·10886705021840·HEALIX ADVANCE Drill Package Contains: 1 Drill ...
ALARIS SMARTSITE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·January 26, 2026
NOVUS SPECTRA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VOLUSON E6/E8/E8EXPERT/E10
FDA 510(k)
FDA Class 2
·Radiology
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
GUIDEWIRE 1.1MM X 15?
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code FZX·November 4, 2014
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code CAW·July 12, 2013
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013