BEUDAMED
    3 results · 13ms · Sources: EU EUDAMED, US FDA

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    Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model number 1016360; b) O2 Enrichment Attachment BX 10 model number 312010; c) O2 Enrichment Attachment Single model number 312710; d) Alice 5, Domestic model number 1017226; e) BIPAP Auto M.W/Humid, W/SmartCard, CA model number CA701HS; f) BIPAP Auto M.W/Humid, W/SmartCard, US model number DS700HS; g) BIPAP Auto M, W/SmartCard, US model number DS700S; h) BIPAP Auto SV W/SmartCard Dom Core model number 1040716; i) BIPAP Harmony, Intl model number 1012823; j) BIPAP Plus M, US model number DS600; k) BIPAP Plus M, W/Humid US model number DS600H; l) BIPAP S/T Core Pkg NA model number 1014248; m) BIPAP S/T North America model number 1012885; n) BIPAP Vision Filter Pack model number 582101; o) Duet LX/BIPAP Pro/Synch Pollen QTY 1 model number 1039611; p) FLXTB, 5 inch STD, 22 mm, CE model number 1006042; q) FLXTB, 6 in Trach 15 mm taper, CE model number 1004968; r) GP UL-Fine Filter 2 pack model number 1006190; s) Incoming Filter 7000, 7001 CPAP model number 7070; and t) Infant ECG Electrodes model number 1016361. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code GWQ·October 15, 2007

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Ulrich Medical USA Inc·May 3, 2017

    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