BEUDAMED
    11 results · 32ms · Sources: EU EUDAMED, US FDA

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    BiPad Hand Activated Disposable Bipolar Electrocautery Cord

    FDA UDI
    Bipad, Inc.·10860001107026·BiPad Hand Activated Disposable Bipolar Electro...

    BiPad Hand Activated Disposable Bipolar Electrocautery Cord Y-Connector

    FDA UDI
    Bipad, Inc.·00860003991800·Y-connector for use with the BiPad Hand activat...

    BiPad Hand Activated Disposable Bipolar Electrocautery Cord

    FDA UDI
    Bipad, Inc.·00860001107012·BiPad Hand Activated Disposable Bipolar Electro...

    Codman Y-Connector, 4-prong device only, unpackaged

    FDA UDI
    Bipad, Inc.·00860003991824·4 pole Y connector

    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

    Non-continuous ventilator accessories under the following brand names: a) RP-BIPAP Flow Pick-Up Tube Kit model number 332185; b) RP-BIPAP M Series Keypad model number 1038122; and c) RP-BIPAP Pro 2 /Plus Tubing Kit model number 1020358. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

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

    RENSTAR PRO

    FDA Adverse Event
    Malfunction ·BIPAP RESPIRONICS INC.·Product code CBK·February 19, 2002

    Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, respiratory failure or to maintain airway patency and provide respiratory support to patients who experience obstructive sleep apnea. Nasal and full face masks are used with this device. The BiPAP Focus is intended for use in acute, sub-acute and intra-hospital transport settings.

    FDA Recall
    Terminated ·Respironics California Inc·Product code MNS·September 22, 2008

    BIPAP AUTO, CORE PACKAGE NA, model number 1017442, filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

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

    BUTTON REPL., G-DEVICE

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC., BIPD DIV.·Product code KNT·May 25, 2000

    SINGULR OLY LRG OVAL FIRM

    FDA Adverse Event
    Injury ·C.R. BARD, INC. BIPD DIV.·Product code KNS·November 8, 2000