83 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
EQUINOXE REVERSE 38MM HUMERAL LINER +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 17, 2022
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIOSORBFX O/M 2.0/2/4 SYSTEM
FDA 510(k)
FDA Class 2
·Dental
EQUINOXE REVERSE 46MM GLENOSPHERE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·October 2, 2024
EQUINOXE REVERSE 42MM HUMERAL LINER +2.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 4, 2023
EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·June 11, 2024
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 20, 2020
E1 RINGLOC BIPOLAR 28X51MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·August 31, 2016
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 3, 2019
RINGLOC HIP SYSTEM ACETABULAR BI-POLAR CUP
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code JDI·June 15, 2017
E1 RINGLOC BIPOLAR 28X43MM
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code HBE·June 22, 2016
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·April 11, 2013
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·March 16, 2011
AXSYM RUBELLA IGG ANTIBODY
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LFX·June 17, 2008
E1 HI-WALL LINER RINGLOC-X
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·June 2, 2017
RINGLOC BI-POLAR ACETABULAR COMPONENT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·December 7, 2016
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 26, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 26, 2019
BD CONNECTA PLUS3 BLUE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·January 24, 2025