BEUDAMED
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    SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Premier X5 Sectional Matrix System

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783004649·Premier X5 Wedge Medium Green-Qty 100

    TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS

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

    DELTA 16 TACT

    FDA 510(k)
    FDA Class 2 ·Radiology

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM F/IM NAIL-STER

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HWC·August 11, 2017

    EDWARDS AORTIC CANNULA, STRAIGHT BEVELED TIP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DWF·April 18, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·April 16, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 4, 2014

    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791RD (Red)

    FDA Recall
    Open, Classified ·Medical Depot Inc.·Product code ITJ·June 14, 2024

    Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791BL (Blue)

    FDA Recall
    Open, Classified ·Medical Depot Inc.·Product code ITJ·June 14, 2024

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015