8 results
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25ms
·
Sources: EU EUDAMED, US FDA
MODEL #510/515 GENERAL TRANSPORT STRETCHER
FDA 510(k)
FDA Class 1
·Physical Medicine
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM51008953140161·Rotary diamond instrument for dental application
BLOOD LANCET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DAVOL POLYPECTOMY SNARE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 25, 2014
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 10, 2010
UNKNOWN ZIMMER HIP
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDI·December 21, 2012
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