44 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KELYNIAM CUSTOM SKULL IMPLANT (CSI)
FDA 510(k)
FDA Class 2
·Neurology
SUPERIOR-LOC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304237186·
MAYBE?MOM MINI OVULATION MICROSCOPE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2025
BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 6, 2023
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2020
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 1, 2024
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 26, 2024
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 24, 2025
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 23, 2024
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC 12/14 40 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 21, 2021
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 9, 2013
PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·September 19, 2014
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·May 26, 2011
BALL HEADS: COCR 12/14 36 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·January 15, 2021
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 26, 2024
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2024
BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 36
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 10, 2023
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·March 13, 2026