BEUDAMED
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    RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PALCERAM 53

    FDA 510(k)
    FDA Class 2 ·Dental

    9611993-2025-051479

    FDA Adverse Event
    Injury ·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·February 26, 2025

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·January 27, 2011

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·April 10, 2013

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·April 4, 2011

    ICON MODULAR SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Malfunction ·BLACKSTONE MEDICAL, INC.·Product code KWQ·May 21, 2008

    BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·January 3, 2023

    BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·January 3, 2023

    RD SET NEO CS-3

    FDA Adverse Event
    Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·January 29, 2021

    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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014