20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tritanium® TL Curved Posterior Lumbar Cage
FDA 510(k)
FDA Class 2
·Orthopedic
MYSPINE MC VERTEBRA L04
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·July 6, 2018
COMPACT AUTO-SAFETY INJECTOR (CASI)
FDA 510(k)
FDA Class 2
·General Hospital
BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
FDA 510(k)
FDA Class 2
·Radiology
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
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SHERBROOKE·Product code FPA·July 23, 2011
ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·June 11, 2013
ACCU-CHEK ® PERFORMA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 15, 2014
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·April 23, 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
1.55MM X 10MM FLUTED TWIST DRL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016
1.55MM X 10MM FLUTED TWIST DRL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016
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
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