9 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Biomet Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
BIOMET HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304256217·
OFFSET MODULAR HEAD PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304308022·
ONDEMAND3D
FDA 510(k)
FDA Class 2
·Radiology
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 15, 2011
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·June 11, 2013
SURGICAL HANDPIECE 3555
FDA Adverse Event
Injury
·KALTENBACK & VOIGT GMBH·Product code EFA·September 17, 2008
E-POLY 32MM +3 MAXROM LINER SZ22
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MAY·September 13, 2013