BEUDAMED
    20 results · 19ms · Sources: EU EUDAMED, US FDA

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    J&S MEDICAL SENTRY URINE DIPSTICK CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AOS CANCELLOUS SCREW 5.0mm x 85.0mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665020144·

    FAC-3 - Class B 21 Kent - 3 Shelf Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620855·FAC-3 - Class B 21 Kent - 3 Shelf Cabinet

    Arsenal

    FDA UDI
    ALPHATEC SPINE, INC.·00840967162331·ANGLED THORACIC SUPRALAMINAR HOOK, LEFT, 8.5mm

    FEMALE LL ADAPTOR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·January 7, 2021

    FEMALE LL ADAPTOR

    FDA Adverse Event
    Malfunction ·Product code FPA·June 9, 2021

    SOMNO STAR & SERIES SLEEP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ULTRASOUND SCANNER, TYPE 1101

    FDA 510(k)
    FDA Class 2 ·Radiology

    Arsenal

    FDA UDI
    ALPHATEC SPINE, INC.·00840967160726·NARROW BLADE 22° OFFSET TRANSVERSE PROCESS HOOK...

    Arsenal

    FDA UDI
    ALPHATEC SPINE, INC.·00840967160184·22° OFFSET TRANSVERSE PROCESS HOOK, LEFT, 8.5mm

    Arsenal

    FDA UDI
    ALPHATEC SPINE, INC.·00840967160368·NARROW BLADE 22° OFFSET TRANSVERSE PROCESS HOOK...

    Arsenal

    FDA UDI
    ALPHATEC SPINE, INC.·00840967160542·22° OFFSET TRANSVERSE PROCESS HOOK, RIGHT, 8.5mm

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 27, 2022

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·March 26, 2013

    TAXUS (R) LIBERTÉ (R)

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 17, 2011

    PULSE GEN MODEL 102R

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·March 28, 2008

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; 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

    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

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018