BEUDAMED
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    EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VuePoint

    FDA UDI
    Nuvasive, Inc.·00887517177476·VuePoint Cross Conn, 3.5x52 Rod

    IV SET AN122 W/O PUMP T-TYPE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·June 21, 2019

    SOMATOM SMILE

    FDA 510(k)
    FDA Class 2 ·Radiology

    6250 ULTRASOUND SYTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD IV SET AN122 W/O PUMP T-TYPE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·June 14, 2019

    ADULT BREATHING CIRCUIT DUAL HEATED

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 15, 2007

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 30, 2014

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 17, 2010

    URETEX SUPPORT PP KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·October 8, 2012

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15 DR/ML,2 CARESITE,146 IN; Catalog Number: 490315. 2. IV ADMN SET,2 CARESITE, SAFEPORT,129 IN.; Catalog Number: 490331. 3. IV ADMIN SET 15 DROPS/ML, CARESITE,98 IN; Catalog Number: 490376.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15 DR/ML,2 CARESITE,146 IN; Catalog Number: 490315. 2. IV ADMN SET,2 CARESITE, SAFEPORT,129 IN.; Catalog Number: 490331. 3. IV ADMIN SET 15 DROPS/ML, CARESITE,98 IN; Catalog Number: 490376.

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FPA·October 29, 2025

    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