BEUDAMED
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    MODIFICATION TO: OASYS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.

    FDA Enforcement
    Class I ·Terminated·Stryker Spine·August 28, 2013

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450558508·

    SINGLE USE ORAL MASK, MODEL HC455A

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PATIENT DRAPE, SURGICAL

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

    BD BACTEC SUBCULTURING/AEROBIC VENTING UNIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JTA·February 25, 2021

    BDRV CANN SCW SS P/T DIA4.5X60MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017

    BDRV CANN SCW SS P/T DIA4.5X52MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017

    PERSONA NATURAL TIBIA

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·May 1, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 16, 2014

    UNKNOWN DEPUY NAIL

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDS·May 12, 2011

    BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·January 14, 2026

    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

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

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