48 results
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20ms
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Sources: EU EUDAMED, US FDA
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531101·MYSTIQUE® MB RT RX 018 U5-5/L3-3 CS HK
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531111·MYSTIQUE® MB RT RX 018 U 5-5/L3-3 CS-BC HK
ENDOFLIP ECD
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531101·IN-OVATION® C Base Rx 018 U5-5/L3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531601·IN-OVATION® C Roncone 018 U5-5/L3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531111·IN-OVATION® C Base Rx 018 U5-5/L3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531001·IN-OVATION® C Base Rx 018 U5-5/L3-3
MYSTIQUE® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K110532101·MYSTIQUE® MB RT RX 022 U 5-5/L3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100531611·IN-OVATION® C Roncone 018 U5-5/L3-3 CS-BC HK
ILT DEFLECTING CATHETER, MODEL C114ND1
FDA 510(k)
FDA Class 2
·Cardiovascular
VISCOPE, MODEL 100P,100S
FDA 510(k)
FDA Class 2
·Cardiovascular
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 21, 2017
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 17, 2023
SUPPORT ARM 177
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code IOY·April 5, 2013
PLUM A+ TRIPLE REFUR
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·September 16, 2014
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 1, 2011
BALL HEADS: COCR BALL HEAD 12/14 32 SIZE S -3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·January 8, 2021
AMISTEM H FEMORAL CEMENTLESS STEM SIZE 1 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·February 27, 2014
VERSAFITCUP CC TRIO ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 26, 2026
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 20, 2024