42 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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G-Fix
FDA 510(k)
FDA Class 2
·Dental
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837088699·
ENDO-EXPRESS (R) HANDPIECE
FDA 510(k)
FDA Class 1
·Dental
GF-UE160-AL5 ULTRASOUND ENDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CUP: VERSAFITCUP CC TRIO 01.26.45.1156 ACETABULAR SHELL CC TRIO NO-HOLE Ø 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 16, 2023
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code NAY·January 11, 2019
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code NAY·January 11, 2019
PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·July 17, 2015
CARELINK
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·June 7, 2013
DHS®/DCS® COUPLING SCREW
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code HWB·October 8, 2014
METASUL LARGE DIAMETER HEAD 52/R
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 28, 2011
COCR BALL HEAD 12/14 28 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·July 22, 2020
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
FDA Enforcement
Class II
·Terminated·Ormco/Sybronendo·March 16, 2016
BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·July 24, 2020
BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·March 27, 2024
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code OLO·March 13, 2019
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
FDA Recall
Terminated
·Ormco/Sybronendo·Product code EKM·February 8, 2016
MASTERLOC FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 23, 2025
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 9, 2019
COCR FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·November 18, 2024