BEUDAMED
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    VISTAKON (SENOFILCON A) SOFT CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HairCheck-DT (Opiates)

    FDA UDI
    Quest Diagnostics·00868586000223·HairCheck-DT (Opiates) is an ELISA test kit use...

    Flex

    FDA UDI
    Diversified Products, Inc.·00037741504276·

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809871623·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND OPEN T...

    Flex

    FDA UDI
    Diversified Products, Inc.·00842894122839·

    Flex

    FDA UDI
    Diversified Products, Inc.·00842894114865·

    DELTA 32; DELTA 32 TACT

    FDA 510(k)
    FDA Class 2 ·Radiology

    PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP

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

    ULTRASONIC IMAGING CATHETER - CORONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code DQO·April 9, 2013

    VENTAK PRIZM

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

    ENDOTAK ENDURANCE RX

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    NEXGEN ARTICULAR SURFACE SIZE F 10 MM HEIGHT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·June 23, 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

    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