18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Equinoxe® Central Screw Baseplate System
FDA 510(k)
FDA Class 2
·Orthopedic
MUST LT 25MM LONG - PEDICLE SCREW Ø6X45 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·January 19, 2024
SILC FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
MUST LT 03.57.035 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X45 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·November 18, 2022
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 18, 2025
PEDICLE SCREW MUST LT 15MM SHORT - PEDICLE SCREW Ø4.5X30 CANN
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·November 8, 2023
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWQ·July 16, 2025
MUST LT 03.59.234 MUST LT 25MM LONG - PEDICLE SCREW Ø7X40 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·February 16, 2022
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·May 27, 2021
MUST LT 15MM SHORT - PEDICLE SCREW Ø8X40 CANN
FDA Adverse Event
Death
·MEDACTA INTERNATIONAL SA·Product code NKB·March 29, 2023
GLIDEWELL HT IMPLANT Ø3.5 X 13 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 25, 2024
SEE H-10
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·September 2, 2011
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·November 6, 2014
ENDOVIVE® STANDARD PEG KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·July 18, 2013
MUST LT MUST LT 25MM LONG - PEDICLE SCREW 6X45 CANN
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·July 7, 2021
MUST LT MUST LT 15MM SHORT - PEDICLE SCREW Ø6X40 CANN
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·November 3, 2021
MECTALIF OBLIQUE (TI PEEK) TIPEEK 10X24X10 L5°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·June 25, 2024