BEUDAMED
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    CROSSFIX II MEMISCAL REPAIR DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    N/A

    FDA UDI
    TETRA MEDICAL SUPPLY CORP.·00614138105140·INDUSTRIAL BACK SUPPORT, LG

    ORTHOSOURCE

    FDA UDI
    ORTHOSOURCE·D9111214130·Lingual Expander 13mm

    MaxFuse VBR, 10 (D) x 12 (W) x 39 (H)

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468055332·

    AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    EUROMI EVA SP6

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929029695·Cervical 12Dx14Wx13H

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929064092·Solid 12Dx14Wx13H

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929034231·Corpectomy, 12Dx14Wx13H 6°

    Matrixx System

    FDA UDI
    NEXXT SPINE, LLC·00889929064634·Corpectomy, 12Dx14Wx13H 0°

    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