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CMDR-2022-00643
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ResMed Astral 150-APAC 2 Ventilator
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ResMed Pty. Ltd. - 1 Elizabeth Macarthur Drive, Bella Vista, NSW, 2153 Australia
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Australia
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17 June 2022
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17 June 2027
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CMDR-2022-00645
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Arrow® Pediatric Two-Lumen Central Venous Catheterization with Blue FlexTip Catheter
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Arrow International, LLC. (Subsidiary of Teleflex, Incorporated) - 3015 Carrington Mill Blvd., Morrisville, North Carolina 27560 USA Mfd. By: Arrow Internacional de Chihuahua S.A. de C.V. - Ave. Washington 3701, Interior Circuito Industrial Alta Tecnologia Edificio 2, 4, 36 and 40, Colonia Panamericana, Chihuahua CP 31200, Mexico
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USA
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17 June 2022
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17 June 2027
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CMDR-2022-00646
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SIMPLEX® Feeding Tube with X-ray Line and Calibration
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Poly Medicure Limited - 232-B 3rd Floor Okhla Industrial Estate, Phase-III, New Delhi-110020, India mfd. By: Poly Medicure Limited - Plot No. 104-105, Sector - 59, HSIIDC Industrial Area, Ballabhgarh, Faridabad, Haryana 121004, India
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India
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01 August 2022
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01 August 2027
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CMDR-2022-00647
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V.A.C. Granufoam Silver Dressing with SensaT.R.A.C. Technology Granufoam Silver Dressing
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KCI Medical Asia Pte. Ltd. Ang Mo Kio Street 65 #01-01, Techpoint Singapore Mfd. By: KCI Manufacturing -ISA Business and technology Park, Dublin Road, Athlone Co., westmeath, Ireland For: KCO USA, Inc. - 12930 IH10 West, San Antonio, Texas, 78249 USA
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Singapore
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25 October 2022
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27 June 2027
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CMDR-2022-00649B
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BluFlux Hollow Fiber Dialyzer, Low Flux, P-Series
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Bain Medical Equipment (Guangzhou) Co. Ltd. 10 Juncheng Road, Eastern Area GETDD, Guangzhou, P.R. China
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China
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27 June 2022
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27 June 2027
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CMDR-2022-00650A
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Neubio-Bold Cochlear Implant Sytem, Internal Receiving Unit (IPU)
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Switz Neubio India PVT. Ltd. Gurugram, Haryana, India
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India
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27 June 2022
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27 June 2027
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CMDR-2022-00650B
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Neubio-Bold Cochlear Implant Sytem, Sound Processing Unit (IPU)
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Switz Neubio India PVT. Ltd. Gurugram, Haryana, India
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India
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27 June 2022
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27 June 2027
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CMDR-2022-00651
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Tuftex Over The Wire Embolectomy Catheter
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Le Maitre Vascular Inc. - #63 Second Avenue, Burlington, MA. 01803, USA
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USA
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29 July 2022
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29 July 2027
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CMDR-2022-00652A
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Arrow Mulit-Lumen Central Venous Catherization Set with Blue FlexTip Arrowg+ard Blue Catheter
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Arrow International LLC subsidiary of Teleflex Inc. - 3015 Carrington Mill Blvd. Morrisville, North Carolina, USA Mfd. By: Arrow Internacional CR A.S. - Jamska 2359/47 nad Sazavou, Czech Republic
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USA
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27 June 2022
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27 June 2027
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CMDR-2022-00652B
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Arrow Mulit-Lumen Central Venous Catherization Set with Blue Flex Tip Catheter
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Arrow International LLC subsidiary of Teleflex Inc. - 3015 Carrington Mill Blvd. Morrisville, North Carolina, USA Mfd. By: Arrow Internacional CR A.S. - Jamska 2359/47 nad Sazavou, Czech Republic
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USA
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27 June 2022
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27 June 2027
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CMDR-2022-00653A
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Karl Storz Cutting Loop, Left Curved
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Karl Storz SE & Co. KG Dr.Karl-Storz-Straße 34 78532 Tuttlingen, Germany
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Germany
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27 June 2022
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27 June 2027
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CMDR-2022-00653B
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Karl Storz Cutting Loop, Right Curved
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Karl Storz SE & Co. KG Dr.Karl-Storz-Straße 34 78532 Tuttlingen, Germany
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Germany
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27 June 2022
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27 June 2027
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CMDR-2022-00654A
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Karl Storz Vaporization Electrode, Bipolar, Ball-Shaped
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Karl Storz SE & Co. KG Dr.Karl-Storz-Straße 34 78532 Tuttlingen, Germany
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Germany
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27 June 2022
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27 June 2027
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CMDR-2022-00654B
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Karl Storz Vaporization Electrode, Bipolar, Extended Length, Ball-Shaped
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Karl Storz SE & Co. KG Dr.Karl-Storz-Straße 34 78532 Tuttlingen, Germany
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Germany
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27 June 2022
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27 June 2027
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CMDR-2022-00654C
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Karl Storz Vaporization Electrode, Bipolar, with Ball end
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Karl Storz SE & Co. KG Dr.Karl-Storz-Straße 34 78532 Tuttlingen, Germany
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Germany
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27 June 2022
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27 June 2027
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CMDR-2022-00655
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Vertex Full Face Mask, Vented, Disposable, Non-Sterile
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Ningbo Shengyurui Medical Appliances, Co. Ltd No. 138, Binhaisi Road, Hangzhou Bay New Zone, Ningbo, Zhejiang Province, China
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China
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27 June 2022
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27 June 2027
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CMDR-2022-00666
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Vertex Nasal Mask, Vented,, Disposable, Non-Sterile
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Ningbo Shengyurui Medical Appliances, Co. Ltd No. 138, Binhaisi Road, Hangzhou Bay New Zone, Ningbo, Zhejiang Province, China
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China
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27 June 2022
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27 June 2027
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CMDR-2022-00667
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Ingevity™+ Leads
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Cardiac Pacemakers, Inc. a subsidiary of Boston Scientific Corporation - 4100 Hamline Avenue North Saint Paul, Minnesota 5512-5798 USA mfd. By: Guidant Puerto Rico B.V., a subsidiary of Boston Scientific Corporation - Dorado Puerto Rico
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USA
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27 June 2022
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27 June 2027
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CMDR-2022-00668
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Venturi Mak Kit, Child with non-kink oxygen tubing 6 diluters
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Non-Change Enterprise Co., Ltd. 6F-11, No, 12, Ln. 609, Sec. 5, ChongxinRd., Sanchong District, New Taipei City 24159, Taiwan
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Taiwan
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27 June 2022
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27 June 2027
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CMDR-2022-00669
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Vertex Nasal Oxygen Cannula, Disposable, Non-Sterile
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Ningbo Shengyurui Medical Appliances Co., Ltd. #138 Binhaisi Road, Hangzhou Bay New Zone, Ningbo, Zheijiang Province, P.R. China
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China
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29 June 2022
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29 June 2027
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