BEUDAMED
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    SUN 125C IONIZATION CHAMBER

    FDA 510(k)
    FDA Class 2 ·Radiology

    LGN PS HIGH FLEX XLPE SZ 1-2 13MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017

    TREGOR DUAL MOBILITY ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 9, 2025

    LGN PS HIGH FLEX XLPE SZ 1-2 13MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 14, 2013

    ARCHITECT TOTAL T3

    FDA Adverse Event
    Malfunction ·A.I.D.D LONGFORD·Product code CDP·September 24, 2014

    ASR UNI FEMORAL IMPL SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 18, 2011

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021