BEUDAMED
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    SUDORMED SWEAT PATCH SPECIMEN CONTAINER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113455·SUPER SHARPS 15 DEG 5MM (BX/5)

    E.S.O. (ELECTRO SENSOR OXI)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Carewear Firefly Wrinkle Reduction

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ACCUPORT

    FDA Adverse Event
    Injury ·ZIMMER KNEE CREATIONS, INC.·Product code FGY·December 20, 2016

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014

    LD304 MATERNITY BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code HDD·November 12, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 8, 2013

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 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