16 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GM HELIX IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 2, 2019
Neodent Implant System GM Line
FDA 510(k)
FDA Class 2
·Dental
GM HELIX IMPLANT 6.0X8 MM
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 21, 2019
GM HELIX IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 20, 2019
GM HELIX ACQUA IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 18, 2019
GM HELIX IMPLANT 6.0X8
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 17, 2019
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197385459·HALSEY TC Needle Holder,straight
130mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197082648·YANG TC Needle Holder
115mm ...
TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
MICRO-TOUCH NITRAFREE
FDA 510(k)
FDA Class 1
·General Hospital
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 28, 2019
VENOUS HARDSHELL CARDIOTOMY RESERVOIR
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTN·October 15, 2014
PROMUS ELEMENT? PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 20, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 27, 2011
ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·August 16, 2023
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024