49 results
·
29ms
·
Sources: EU EUDAMED, US FDA
RAYSCAN A-EXPERT 3D
FDA 510(k)
FDA Class 2
·Radiology
INION CPS 2.5/2.8 SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
VERSAFITCUP CC TERMINAL CUP IMPACTOR
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MEH·June 4, 2014
NA
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·December 4, 2014
ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 20, 2018
VERSAFITCUP CC HIGHCROSS PE LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 31, 2013
VERSAFITCUP FLAT PE HC LINER Ø 36 / E
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·April 26, 2017
FOLYSIL SILICONE CATHETER
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code EZL·March 28, 2024
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·May 21, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014
GORE VIABAHN ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code NIP·June 10, 2011
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·December 19, 2017
STEM: AMISTEM H HA COATED STD STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 11, 2019
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 5, 2024
VERSAFITCUP FLAT PE HC LINER Ø 32/E
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·July 26, 2016
STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD SIZE 1
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·February 28, 2020
AMISTEM H CEMENTLESS STEM #4 LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code MEH·February 9, 2015
CUP: VERSAFITCUP ACETABULAR SHELL 58
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·September 3, 2020
BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2020