9 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XprESS ENT Dilation System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Sklar®
FDA UDI
SKLAR CORPORATION·10649111282034·TC METZ SCISS CVD SER B/B 9"
UNIMAX SUCTION IRRIGATION SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEPUY PEAK FX HIP PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 10, 2018
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·October 10, 2014
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·June 11, 2013
PROLENE HERNIA MESH 3DP PATCH
FDA Adverse Event
Injury
·ETHICON (J + J)·Product code FTL·July 13, 2011
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020