BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SIMPLICITY SOFT INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRILOGY 200

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·May 7, 2014

    SURGISTOOL

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIVISION·Product code FZM·November 12, 2010

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    HL CORP. (SHENZHEN)·Product code FNL·January 8, 2013

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    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

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025