BEUDAMED
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    RAZOR Single-Use Acetabular Reamer

    FDA UDI
    Razor Medical Instruments, Inc.·00850022768002·Acetabular Orthopedic Reamer, 46mm

    Intubation Guide Kit

    FDA UDI
    Nar Medical Depot, LLC·00860009615533·AIR Q KIT - SZ 3

    Haas Expander

    FDA UDI
    ALLESEE AOA-PRO·00889989038705·Haas Expander

    INSTRUMENT

    FDA UDI
    Howmedica Osteonics Corp.·07613327014464·PATELLA CUTTER

    Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 10, 2023

    ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·STAARVISC II

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

    X3 TRIATHLON CS INSERT #6 9MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·September 3, 2014

    CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DYB·May 3, 2022

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 19, 2024

    640G INSULIN PUMP MMT-1710K

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 27, 2020

    ARCH KOH-EFFICIENT

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HEW·February 19, 2025

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·Titan Inflatable Penile Prosthesis

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·COEASE SODIUM HYALURONATE

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·ALPHA I INFLATABLE PENILE PROSTHESIS