126 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110
FDA 510(k)
FDA Class 2
·Radiology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970560·
EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM)
FDA 510(k)
FDA Class 2
·Orthopedic
CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BAG SPIKE W/CLAVE
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·June 29, 2016
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
SENSOR BSA
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·May 21, 2013
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·September 26, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011
ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 20, 2018
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 11, 2019
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
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 11, 2019
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
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·April 29, 2019
VERSAFITCUP FLAT PE HC LINER Ø 32/E
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·July 26, 2016