BEUDAMED
    24 results · 22ms · Sources: EU EUDAMED, US FDA

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    Swedge™ Pedicle Screw Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Mariner Cortical

    FDA UDI
    Seaspine Orthopedics Corporation·10889981168681·CORTICAL SHANK, Cannulated, 7.0 X 45

    Mariner Cortical

    FDA UDI
    Seaspine Orthopedics Corporation·10889987168685·CORTICAL SHANK, Cannulated, 7.0 X 45

    OCTO

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ZIRBLANK-PS AND ZIRBLANK-FS

    FDA 510(k)
    FDA Class 2 ·Dental

    TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 15, 2024

    MINIMAX STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 24, 2025

    MINIMAX RIGHT ANATOMICAL BROACH SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LXH·February 20, 2020

    NAVIO HANDPIECE

    FDA Adverse Event
    Malfunction ·BLUE BELT TECHNOLOGIES·Product code OLO·April 24, 2020

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 6, 2019

    VA LOCKSCR Ø2.4 SELF-TAP L24 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·June 14, 2013

    PREM PLUS HIP SYSTEM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·July 13, 2011

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·September 24, 2008

    MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2017

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·April 4, 2019

    CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 4, 2019

    CUP: VERSAFITCUP ACETABULAR SHELL Ø 48

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·December 27, 2019

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 8, 2021

    TRU CC FEMORAL SIZE 1 LEFT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 15, 2025

    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198

    FDA Enforcement
    Class I ·Ongoing·Tandem Diabetes Care, Inc.·September 3, 2025