8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RANGE/MESA/DENALI SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TORNIER AEQUALIS REVERSE SHOLDER PROSTHESIS
FDA Adverse Event
Malfunction
·TORNIER INC.·Product code HSD·June 18, 2009
AEQUALIS REVERSED SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
MASTERSCREEN IOS
FDA 510(k)
FDA Class 2
·Anesthesiology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
TRANSVENE SVC/CS
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWS·June 28, 2011
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014