59 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUTUREFIX Curved Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Back-n-Shape II
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357630349·
Ceramco® II Silver™
FDA UDI
Dentsply International Inc.·D0011630340·
GENESYS SPINE INTERBODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AIR-FLEX WITH AUTO-DISTRACTION
FDA 510(k)
FDA Class 2
·Physical Medicine
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·December 21, 2018
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·May 29, 2019
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·October 10, 2014
XIA 3 TITANIUM TORQUE WRENCH
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code LXH·June 11, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 15, 2011
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019
1030489-2019-01511
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·December 31, 2019
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 1, 2020
1030489-2019-01423
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019
GLIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 9, 2025
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 23, 2022
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 3, 2025
RADIFOCUS GUIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 12, 2024
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQX·August 30, 2023