BEUDAMED
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    ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    infinity OCTAGON TL WP Healing abutment GH 3.0mm

    FDA UDI
    Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50937321·Healing abutment GH 3.0mm for infinity OCTAGON ...

    BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GELZONE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 21, 2025

    THORACENTESIS SET

    FDA Adverse Event
    Injury ·ARROW INTERNATIONAL INC.·Product code JOL·May 1, 2013

    CANNULATED 2.5MM HEXAGONAL SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HXX·September 16, 2014

    RSP SHOULDER

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code KWS·April 21, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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