755 results
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39ms
·
Sources: EU EUDAMED, US FDA
KALIX
FDA Adverse Event
Injury
·NEWDEAL SA·Product code HWC·February 19, 2003
BOLD
FDA Adverse Event
Malfunction
·NEWDEAL SA·Product code HWC·February 19, 2003
KALIX
FDA Adverse Event
Injury
·NEWDEAL SA·Product code HWC·April 16, 2003
KALIX
FDA Adverse Event
Injury
·NEWDEAL SA·Product code HWC·May 14, 2002
Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S & 121820S
FDA Enforcement
Class II
·Terminated·NewDeal SA·July 25, 2018
UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S
FDA Enforcement
Class II
·Terminated·NewDeal SA·July 25, 2018
TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S
FDA Enforcement
Class II
·Terminated·NewDeal SA·July 25, 2018
ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S
FDA Enforcement
Class II
·Terminated·NewDeal SA·July 25, 2018
ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S
FDA Enforcement
Class II
·Terminated·NewDeal SA·July 25, 2018
ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S
FDA Recall
Terminated
·NewDeal SA Immeuble Sequoia·Product code HRS·May 22, 2018
ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S
FDA Recall
Terminated
·NewDeal SA Immeuble Sequoia·Product code HRS·May 22, 2018
TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S
FDA Recall
Terminated
·NewDeal SA Immeuble Sequoia·Product code HRS·May 22, 2018
UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S
FDA Recall
Terminated
·NewDeal SA Immeuble Sequoia·Product code HRS·May 22, 2018
Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S & 121820S
FDA Recall
Terminated
·NewDeal SA Immeuble Sequoia·Product code HRS·May 22, 2018
ACHILLON SYSTEM
FDA Adverse Event
Malfunction
·NEWDEAL SAS·Product code HCF·December 16, 2016
COMPRESSION PLATE 2 HOLE 30MM
FDA Adverse Event
Malfunction
·NEWDEAL SAS·Product code HRS·December 9, 2016
SCREWDRIVER TORX T7
FDA Adverse Event
Malfunction
·NEWDEAL SAS·Product code HXX·November 15, 2016
HALLU LOCK PLATE UNSPECIFIED DIMENSIONS
FDA Adverse Event
Injury
·NEWDEAL SAS·Product code HRS·August 11, 2015
SPIN SCREW DIAM. 2MM LG 14MM
FDA Adverse Event
Malfunction
·NEWDEAL SAS·Product code HWC·September 25, 2015
DEVICE FOR NAIL FIXATION
FDA Adverse Event
Malfunction
·NEWDEAL SAS·Product code LXH·July 16, 2015