8 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ROSA® Shoulder System
FDA 510(k)
FDA Class 2
·Neurology
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·July 2, 2002
COMPACT DIGITAL CARDIAC CAMERA (CDCC)
FDA 510(k)
FDA Class 2
·Radiology
RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
FDA Adverse Event
Malfunction
·AOMORI OLYMPUS CO., LTD.·Product code GEI·February 13, 2023
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE LTD·Product code FRN·November 18, 2008
SOFTCLIX ® PLUS GT LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·September 2, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·July 18, 2013