20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENZA-A Titanium ALIF
FDA 510(k)
FDA Class 2
·Orthopedic
MYSPINE MC VERTEBRA L04
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·July 6, 2018
UNITY NETWORK ID
FDA 510(k)
FDA Class 2
·Cardiovascular
TRAUSON BONE PLATE
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
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 23, 2011
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·June 9, 2013
ONE TOUCH ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·September 23, 2008
NEOCIS GUIDANCE SYSTEM
FDA Adverse Event
Injury
·NEOCIS INC.·Product code PLV·September 13, 2019
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
ALINITY S HBSAG REAGENT KIT
FDA Adverse Event
Injury
·ABBOTT IRELAND·Product code QHM·October 4, 2022
ALINITY S HBSAG REAGENT KIT
FDA Adverse Event
Injury
·ABBOTT IRELAND·Product code QHM·November 29, 2022
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024