34 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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t:flex Insulin Delivery System
FDA 510(k)
FDA Class 2
·General Hospital
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK
FDA 510(k)
FDA Class 2
·Orthopedic
SONALIS, MODEL 2000
FDA 510(k)
FDA Class 2
·Radiology
AMISTEM H, HA COATED STEM SIZE 3 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2016
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 6, 2025
BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø 36 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·November 16, 2023
AMISTEM C FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 27, 2026
AMISTEM C FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 26, 2026
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·May 28, 2013
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·September 22, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 28, 2011
LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø40/G
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 14, 2022
AMISTEM C FEMORAL STEMS
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JDI·July 17, 2025
LINER: MPACT FLAT PE HC LINER Ø36/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 21, 2018
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 24, 2019
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 17, 2020
AMISTEM C FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 9, 2025
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 27, 2018
AMISTEM C FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 20, 2025
CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·September 17, 2020