11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Endoscope Model EG-580UT and Endoscope Model EG-580UR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Oticon
FDA UDI
Oticon A/S·05714464007455·AGXO F500 MINIRITE R C044
iTero Lumina Pro Mobile
FDA UDI
Align Technology, Inc.·00816063022237·iTero Lumina Pro US Mobile Configuration
BD BBL™ Oxacillin Screen Agar
FDA UDI
BECTON, DICKINSON AND COMPANY·10382902219528·BD BBL™ Oxacillin Screen Agar
HIVOX DREAMATE DM-800
FDA 510(k)
FDA Class 2
·Neurology
CrossGlide ETS Plus
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FPA·August 17, 2011
AUTOPULSE® RESUSCITATION MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code DRM·November 3, 2014
2000PLUS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·July 5, 2013
Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JTZ·July 28, 2005
BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strains are resistant to penicillinase-resistant penicillins (PRPs), such as methicillin, oxacillin and nafcillin. Since the method to detect MRSA uses the same inoculum as the Bauer-Kirby antimicrobial disc susceptibility test procedure, the oxacillin screen test may be conveniently performed on isolates at the same time as routine susceptibility testing.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code JTZ·April 20, 2011