BEUDAMED
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    MODIFICATION TO 30 EXTENSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ES™ TROCHANTERIC NAIL, RIGHT, Ø10mm x 39cm x 125°

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665022162·

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854006924·ULTRAPOWER BUR, OVAL (LIME), 4 MM X 8 MM

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450157367·

    MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    3002806535-2018-01155

    FDA Adverse Event
    Injury ·October 24, 2018

    RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 10, 2019

    OXF ANAT BRG LT X-SM SZ 5 PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·October 24, 2018

    OCTYLSEAL

    FDA Adverse Event
    Malfunction ·CHEMENCE MEDICAL PRODUCTS INC·Product code MPN·March 11, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 19, 2014

    CLARION

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·March 24, 2008

    8015 ALARIS SYSTEM PC UNIT

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·December 18, 2020

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014