7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DIATEMP ELECTROSURGICAL PEN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TOXO-CUBE
FDA 510(k)
FDA Class 2
·Microbiology
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·January 15, 2013
FLEXTEND
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·January 10, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 23, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015