7 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHOTOTHERAPEUTIX MODEL 2400B
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
FDA 510(k)
FDA Class 2
·Dental
SHAPE LOCKING ENDOSCOPIC OVERTUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·January 29, 2013
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·December 21, 2010
UNKNOWN DEPUY ACETUBULAR SCREW
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HWC·July 15, 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