9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Borrelia B31 ViraChip IgM Test Kit
FDA 510(k)
FDA Class 2
·Microbiology
Biomet® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868310751·
BIOMET HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304256736·
RUNTHROUGH NS
FDA 510(k)
FDA Class 2
·Cardiovascular
PREPEX SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 11, 2013
FOUNDATION HIP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code LPH·June 15, 2011
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FMF·September 9, 2008
Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014