19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MYSPINE MC VERTEBRA L04
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·July 6, 2018
MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments
FDA 510(k)
FDA Class 2
·Orthopedic
REDUCTION CANNULATED PEDICLE SCREW 5X45
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·February 17, 2023
MYSPINE S01 DRILL BASED GUIDE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·December 12, 2018
MYSPINE-MC DRILL GUIDE L03
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PQC·May 26, 2023
MYSPINE STOPPER SLEEVE 30 MM, DRILL2.7 - LUMBAR
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LXH·February 26, 2020
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·July 16, 2025
MYSPINE UNILATERAL LEFT GUIDE S01
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024
ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·January 10, 2024
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2024
MYSPINE MYSPINE MC DRILL BASED GUIDE L04
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PQC·February 14, 2020
NUFACE PLUS
FDA 510(k)
FDA Class 2
·Neurology
VACCESS PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·June 11, 2013
BD SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO.·Product code FMF·September 19, 2014
NEOCIS GUIDANCE SYSTEM
FDA Adverse Event
Injury
·NEOCIS INC.·Product code PLV·September 13, 2019
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 14, 2022
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017