BEUDAMED
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    AR-1600G AUTO-REFRACTOMETER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Herpes Simplex Virus Type 1 / HSV-1 IgG IFA 96 Test

    FDA UDI
    Hemagen Diagnostics, Inc.·G5229025001·For the detection and titration of HSV-1 IgG an...

    MODIFICATION TO PROFLU+ ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    X-POSURE SYSTEM VERSION 2 RAD

    FDA 510(k)
    FDA Class 2 ·Radiology

    M2A-MAGNUM PF CUP 50ODX44ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·April 30, 2026

    M2A-MAGNUM MOD HD SZ 44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·April 30, 2026

    GMK-SPHERE TIBIAL INSERT FIXED FLEX #4/10 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 4, 2021

    ACTIVA

    FDA Adverse Event
    Malfunction ·NEURO - VILLALBA·Product code MHY·June 30, 2014

    COULTER® LH 500 INSTRUMENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·January 8, 2013

    HIRES 90K

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·November 11, 2010

    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