BEUDAMED
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    SR-130

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACE Surgical Pga Und 4-0 18" Dsm13

    FDA UDI
    Surgical Specialties México, S. de R.L. de C.V.·00848782023127·003-0494 Pga Und 4-0 18" Dsm13

    MIMIX BONE REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    2027971-2022-030494

    FDA Adverse Event
    Injury ·NOBEL BIOCARE USA, LLC·Product code DZE·January 11, 2022

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·March 27, 2013

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    FDA Adverse Event
    Injury ·COVIDIEN FORMERLY TYCO HEALTHCARE·Product code JOH·March 18, 2011

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICRO TYPING SYSTEMS, INC.·Product code KSZ·April 17, 2008

    LIFEWISE BLOOD PRESSURE MONITOR

    FDA Adverse Event
    Injury ·RADIOSHACK·Product code DXN·October 20, 2004

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018