BEUDAMED
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    AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MaxFuse VBR, 10 (D) x 12 (W) x 61 (H)

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468055769·10 (D) x 12 (W) x 61 (H)

    Logical High Wall Liner

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215124564·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973837·

    ER150/M2

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

    ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929064900·Corpectomy, 12Dx14Wx56H 0°

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929040751·Corpectomy, 12Dx14Wx56H 6°

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 23, 2025

    GMK-SPHERE PATELLA RESURFACING SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 25, 2024

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2019

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2025

    GMK SPHERE FEMORAL COMPONENT SIZE 4 LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2016

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 22, 2021

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 10, 2021

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 2, 2025

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 30, 2026

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 26, 2019

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    FDA Adverse Event
    Malfunction ·CONVATEC, INC.·Product code KNT·July 29, 2014