9 results
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18ms
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Sources: EU EUDAMED, US FDA
AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ORA Implant Abutment 2.0mm Cuff (AK)
FDA UDI
STERNGOLD DENTAL LLC·00841549113116·The ORA System is indicated for use with dental...
CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE
FDA 510(k)
FDA Class 2
·Cardiovascular
BIODYNE INSTRUMENT WIPES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DRB SSP UNITRAY KIT WITH TAQ POLYMERASE
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES CORPORATION·Product code MZI·January 23, 2014
REGENEREX RINGLOC 62MM MULTI HOLE ACETABULAR CUP SZ 25 W/ LOCK RING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·November 22, 2010
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 1, 2014
RELIEVA FLEX SINUS GUIDE CATHETER
FDA Adverse Event
Malfunction
·ACCLARENT·Product code LRC·December 3, 2012
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013