BEUDAMED
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    Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Oticon

    FDA UDI
    Oticon A/S·05707131287533·RIA2, RITE 312 WL SGR

    SAV

    FDA UDI
    Diversified Products, Inc.·00037741915072·

    IRIS Anterior Cervical Plate System

    FDA UDI
    Life Spine, Inc.·00190837060879·Iris Removal Sleeve

    IRIS Anterior Cervical Plate System

    FDA UDI
    Life Spine, Inc.·00190837060886·Iris inner core removal

    MODIFICATION TO: INION OTPS BIODEGRADABLE PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS

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

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 20, 2021

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 9, 2023

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 8, 2022

    IHEARTEST

    FDA Adverse Event
    Malfunction ·IHEAR MEDICAL, INC.·Product code EWO·August 17, 2022

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 4, 2024

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·October 7, 2014

    ACUITY CENTRAL MONITORING

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code DSI·May 29, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 10, 2011

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code FAS·May 24, 2023

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 6, 2023

    HF-RESECTION ELECTRODE, LOOP

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 2, 2023

    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015