10 results
·
32ms
·
Sources: EU EUDAMED, US FDA
MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 21, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 21, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 21, 2024
UNILAB CULTURING SET
FDA 510(k)
FDA Class 2
·General Hospital
RESPIRONICS PERFORMAX SE TOTAL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
ELLIPSE DR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 24, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·January 2, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 3, 2010
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014