BEUDAMED
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    CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CLINITEK STATUS+

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JHI·December 2, 2019

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978959047·DISTRACTOR 9091216 16MM OBLIQUE 8 DEG

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065746·INTRAORAL ELASTICS 6,5 oz 1/4" red

    NA

    FDA UDI
    STERILMED, INC.·10888551018043·BUR CARBIDE MICRO SIDE-CUTTING STRAIGHT MEDIUM ...

    CONMED

    FDA UDI
    Conmed Corporation·10845854007464·SIDECUTTING BUR, MEDIUM, STRAIGHT, 1.2 X 4.9 MM

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450226254·

    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0112160·Rasp, 16 and 18 mm

    POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PVC FREE INTRAVASCULAR ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PREMICATH

    FDA Adverse Event
    Malfunction ·VYGON USA·Product code LJS·March 9, 2023

    PANORAMA CENTRAL STATION W/ TELEPACK

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTP·September 16, 2014

    IN TOUCH ZU

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·April 20, 2011

    PREMICATH

    FDA Adverse Event
    Malfunction ·VYGON USA·Product code LJS·January 24, 2023

    PUMP 1886 780G OUS BLE PUMP MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 3, 2024

    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012