8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACUFEX(R) ARTHROPLASTY INSTRUMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
PUMP CONNECTIVITY INTERFACE
FDA 510(k)
FDA Class 2
·General Hospital
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
CARE ASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·April 23, 2014
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 4, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·December 22, 2010
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025
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