46 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENDO A CLASS
FDA 510(k)
FDA Class 1
·Dental
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011123582000·Super hard metal burs, with cross toothing cut,...
I-STAT KAOLIN ACT TEST
FDA 510(k)
FDA Class 2
·Hematology
KELYNIAM CUSTOM SKULL IMPLANT (CSI)
FDA 510(k)
FDA Class 2
·Neurology
SOLID SCREWDRIVER, SMALL
FDA Adverse Event
Malfunction
·CONVENTUS FLOWER ORTHOPEDICS·Product code HXX·August 17, 2021
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
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
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 26, 2014
LIGASURE ATLAS HANDSWITCHING 37CM
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·June 10, 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
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 30, 2025