18 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Extremity Staple
FDA 510(k)
FDA Class 2
·Orthopedic
K231485
FDA Adverse Event
Malfunction
·BETA BIONICS, INC.·Product code QFG·October 25, 2025
MPACT DM LINER CONVERTER
FDA 510(k)
FDA Class 2
·Orthopedic
Scrambler Therapy Technology (Model ST-5A)
FDA 510(k)
FDA Class 2
·Neurology
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC 12/14 Ø 28 SIZE L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 14, 2021
MPACT DM DOUBLE MOBILITY HC LINER Ø 50/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·July 30, 2019
LINER: MPACT DM DOUBLE MOBILITY HC LINER 22.2/DMC
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·December 7, 2020
TENDRIL STS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 17, 2013
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 31, 2024
PS TIBIAL INSERTS SZ 5, 18MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 31, 2024
LINER: MPACT DM DM CONVERTER TIN COATED D/DMB
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 27, 2024
STEM: M-VIZION PROXIMAL BODY Ø20MM L 90MM STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 9, 2024
PSX INTERBODY SYSTEM
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code MAX·April 29, 2025
CUP: MPACT ACETABULAR SHELL Ø56 MULTI-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·March 1, 2022
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 13, 2022
MPACT DOUBLE MOBILITY SHELLS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·February 21, 2024