12 results
·
23ms
·
Sources: EU EUDAMED, US FDA
NEUTRASAL
FDA 510(k)
FDA Unclassified
·Unknown
Temena
FDA UDI
Temena GmbH·03700339710119·Epidural needle Rodiera 17/18G x 120 mm
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT
FDA 510(k)
FDA Class 2
·Ophthalmic
MILLENNIA ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 18, 2025
COCR FEMORAL HEAD
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·February 23, 2018
PASSPORT 2 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
SPL LEAD, TRANSVENOUS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., INC., CRMD·Product code NVY·January 13, 2014
RESOLUTION II CLIP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·May 17, 2011
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·September 16, 2022
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL UM-D·Product code FPA·January 15, 2025
GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.
FDA Enforcement
Class II
·Terminated·GE Healthcare·November 18, 2015