7 results
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18ms
·
Sources: EU EUDAMED, US FDA
3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU
FDA 510(k)
FDA Class 1
·Microbiology
ROCHE REAGENTS REAGENT FOR URIC ACID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ARCHITECT TSH
FDA Adverse Event
Malfunction
·A.I.D.D LONGFORD·Product code JLW·June 25, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·January 3, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·November 5, 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