BEUDAMED
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    NAVIGUS II TRAJECTORY GUIDE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040056578·Zirlux Multi Anterior C2,98.5X12

    G-aenial™

    FDA UDI
    Gc America Inc.·D0470123661·G-aenial Universal Injectable A3, Dispensing Ti...

    FALLS CREEK

    FDA UDI
    FGX INTERNATIONAL INC.·00193033382752·

    FALLS CREEK

    FDA UDI
    FGX INTERNATIONAL INC.·00719283536280·

    K012364

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 3, 2015

    QUEST MPS BACK-UP SYSYEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DISPOSABLE STORAGE CAP

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

    COMFORT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 17, 2025

    CRANIAL ACCESS KIT W/TWIST LOCK DRILL GUARD

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORP.·Product code HBF·January 20, 2005

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 20, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 9, 2011

    GLV EXAM ESTEEM PF STRETCHY NITRILE MD

    FDA Adverse Event
    Other ·CARDINAL HEALTH·Product code FMC·March 13, 2008

    Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·February 17, 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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019