11 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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