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CMDR-2021-00031A
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CHARISMA CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
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Cardiac Pacemakers, Inc. A wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation - MN, USA mfd. By: Boston Scientific Limited - Ireland
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Ireland
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19 April 2021
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19 April 2026
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CMDR-2021-00031B
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CHARISMA X4 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
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Cardiac Pacemakers, Inc. A wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation - St. Paul, MN, USA mfd. By: Boston Scientific Limited - Clonmel, Co., - Tipperary, Ireland
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Ireland
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19 April 2021
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19 April 2026
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CMDR-2021-00032A
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TRIFECTA™ VALVE WITH GLIDE™ TECHNOLOGY VALVE
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Abbott Medical (Singapore) Pte. Ltd. Formerly St. Jude Medical of the Manufacturer (Singapore) Pte. Ltd. - Singapore mfd. By: St. Jude Medical - St. Paul, MN, USA
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USA
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19 April 2021
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19 April 2026
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CMDR-2021-00032B
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TRIFECTA™ VALVE WITH GLIDE™ TECHNOLOGY VALVE
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Abbott Medical (Singapore) Pte. Ltd. Formerly St. Jude Medical of the Manufacturer (Singapore) Pte. Ltd. - Singapore mfd. By: St. Jude Medical Brazil LTDA - Belo Horizante, Brazil For: St. Jude Medical - St. Paul, MN, USA
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USA
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19 April 2021
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19 April 2026
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CMDR-2021-00033
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BILE T-TUBE
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Well Lead Medical Co., Ltd. - Hualong 511434, Panyu, Guangzhou, People's Republic of China
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China
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19 April 2021
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19 April 2026
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CMDR-2021-00034
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IRASAFETY™ CONTACT-ACTIVATED LANCET
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Hebei Xinle Sci & Tech Co., Ltd. - Hebei Province, P.R. China
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China
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19 April 2021
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19 April 2026
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CMDR-2021-00035
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KANGBAO STERILE HYPODERMIC SYRINGE WITH NEEDLE FOR SINGLE USE
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Jiangsu Kangbao Medical Equipment Co., Ltd. - Yangzhou, China
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China
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29 July 2021
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19 April 2023
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CMDR-2021-00036
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TROCLOSE 1200™ BLADELESS TROCAR WITH CLOSURE SYSTEM, SINGLE-USE
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SRS Life Sciences Pte. Ltd. - Singapore mfd. By: Gordian Surgical Ltd. - M.P. Migsav, Israel
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Singapore
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19 April 2021
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19 April 2026
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CMDR-2021-00037
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WATSON RAPID DIGITAL THERMOMETER
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Hangzhou Hua'an Medical & Health Instruments Co., Ltd. - Hangzhou, Zhejiang, China
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China
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19 April 2021
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19 April 2026
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CMDR-2021-00038
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GAMMEX® LATEX UNDEGLOVE LATEX SURGICAL GLOVES POWDER-FREE WITH MOISTURIZER
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Ansell Global Trading Center (Malaysia) Sdn. Bhd. - Cyberjaya, Malaysia mfd. By: Ansell N. P. Sdn. Bhd. - Melaka Malaysia For: Ansell Healthcare Europe N.V. - Brussels, Belgium
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Belgium
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30 April 2021
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30 April 2026
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CMDR-2021-00039
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PAJUNK E-CATH KIT ACC. TSUI E-CATHETER
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Pajunk GmbH Medizintechnologie, Geisingen, Germany
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Germany
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30 April 2021
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30 April 2026
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CMDR-2021-00040
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ROTAPRO PRE-CONNECTED EXCHANGEABLE BURR CATHETER AND BURR ADVANCING DEVICE
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Boston Scientific Corporation - MA, USA mfd. By: Boston Scientific Limited - Cork, Ireland
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USA
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30 April 2021
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30 April 2026
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CMDR-2021-00041
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MEDI-GRIP® LATEX STANDARD LATEX SURGICAL GLOVES POWDER-FREE, STERILE
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Ansell Global Trading Center (Malaysia) Sdn. Bhd. - Cyberjaya, Malaysia mfd. By: Ansell N. P. Sdn. Bhd. - Melaka Malaysia For: Ansell Healthcare Europe N.V. - Brussels, Belgium
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Belgium
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30 April 2021
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30 April 2026
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CMDR-2021-00042
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GAMMEX® LATEX TEXTURED LATEX SURGICAL GLOVES POWDER-FREE, STERILE
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Ansell Global Trading Center (Malaysia) Sdn. Bhd. - Cyberjaya, Malaysia mfd. By: Ansell N. P. Sdn. Bhd. - Melaka Malaysia For: Ansell Healthcare Europe N.V. - Brussels, Belgium
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Belgium
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30 April 2021
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30 April 2026
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CMDR-2021-00043
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MEDCOMP® SPLIT STREAM® CATHETER SET WITH STYLET (SHEATHLESS TECHNIQUE)
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Medical Components, Inc. dbe Medcomp - Pennsylvania, USA mfd. By: Martech Medical Products, S.de R.L. de C.V. - Baja California, Mexico
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USA
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30 April 2021
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30 April 2026
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CMDR-2021-00044
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ROTAPRO ADVANCER BURR ADVANCING DEVICE
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Boston Scientific Corporation - Marlborough, MA, USA mfd. By: Boston Scientific Limited - Cork, Ireland
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USA
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30 April 2021
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30 April 2026
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CMDR-2021-00045
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SJM SEGUIN™ ANNUPLASTY RING FOR MITRAL VALVE REPAIR
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Abbott Medical (Singapore), Pte. Ltd. - Alexandra Technopark, Singapore mfd. By: St. Jude Medical PR, LLC - Caguas, Puerto Rico For: St. Jude Medical - MN, USA
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USA
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30 April 2021
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30 April 2026
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CMDR-2021-00046
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NANOSOFT™ MICRONEEDLES
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NanoPass Technologies, Ltd. - Nes Ziona, Israel
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Israel
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03 May 2021
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03 May 2026
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CMDR-2021-00047
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MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER
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Microlife AG - Widnau, Switzerland mfd. By: Onbo Electronic (Shenzhen) Co., Ltd. - Shenzhen, China
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China
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15 June 2021
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03 May 2026
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CMDR-2021-00048A
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ARROW LARGE-BORE MULTI-LUMEN CENTRAL VENOUS CATHERIZATION SET WITH BLUE FLEXTIP® CATHETER FOR HIGH VOLUME INFUSIONS
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Arrow International, Inc. (Subsidiary of Teleflex, Inc.) - Bernville Rd., Reading, PA, USA mfd. By: Arrow International CR, A.S. - Zdar nad Sazavou, Czech Republic
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USA
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03 May 2021
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03 May 2026
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