BEUDAMED
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    VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040020385·Natural Elegance Flowable Tips

    BD ULTRA FINE PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·October 21, 2020

    MODIFICATION TO HANDMASTER

    FDA 510(k)
    FDA Class 2 ·Neurology

    RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DEPUY PINNACLE 100 ACETABULAR CUP SYSTEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·March 21, 2013

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·March 17, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 28, 2008

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCE·Product code NPT·March 5, 2024

    EDWARDS ESHEATH INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYB·March 7, 2024

    LOGIC PSC TIB INS SZ 5 17MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 14, 2023

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·March 5, 2024

    EDWARDS SAPIEN 3 VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·March 5, 2024

    THREE PEG PATELLA 38MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·November 22, 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

    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