BEUDAMED
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    MODIFICATION OF SEROCARD RUBELLA IGG TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Ti Screw ES

    FDA UDI
    Biomet Orthopedics, LLC·00880304009677·

    5.0MM TITANIUM SCREW ANCHOR WITH NEEDLES

    FDA Adverse Event
    Malfunction ·BIOMET SPORTS MEDICINE·Product code HWC·October 11, 2016

    MULITPLE MALE LATX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GYRUS ACMI BIOCOAG PROBE

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

    5.0MM TI W/ MAXBRAID NDLS

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·February 9, 2022

    5.0MM TI SCREW ANCHORS W/ MAXBRAID NEEDLES

    FDA Adverse Event
    Injury ·BIOMET SPORTS MEDICINE·Product code HWC·October 18, 2011

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·June 30, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·November 12, 2010

    5.0MM TI W/ MAXBRAID NDLS

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·February 9, 2022

    Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·November 12, 2025

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    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