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    CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575182817·Knee femur prosthesis trial - Megasystem-C Tumo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575182800·Knee femur prosthesis trial - Megasystem-C Tumo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575182770·Knee femur prosthesis trial - Megasystem-C Tumo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575185696·Knee femur prosthesis trial - Megasystem-C Tumo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575185689·Knee femur prosthesis trial - Megasystem-C Tumo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575182626·Knee femur prosthesis trial - Megasystem-C Tumo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575182794·Knee femur prosthesis trial - Megasystem-C Tumo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575182763·Knee femur prosthesis trial - Megasystem-C Tumo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575182787·Knee femur prosthesis trial - Megasystem-C Tumo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575182619·Knee femur prosthesis trial - Megasystem-C Tumo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575185665·Knee femur prosthesis trial - Megasystem-C Tumo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575182657·Knee femur prosthesis trial - Megasystem-C Tumo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575186303·Knee femur prosthesis trial - Megasystem-C Tumo...

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DIREXION? HI-FLO?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·August 11, 2025

    DIREXION HI-FLO FATHOM-16 SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 13, 2025

    DIREXION?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·August 19, 2025

    DIREXION? TRANSEND?-14 SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·January 26, 2026