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CMDR-2023-02075
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Jafron High Flux Hemodialyzers
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Jafron Blood Purification Technologies Co., Ltd. Building 11, No. 98, Technology Sixth Road, High-Tech Zone, 519080 Zhuhai, Guangdong, People's Republic of China
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China
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09 November 2023
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09 November 2028
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CMDR-2023-02076
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Trima Accel LRS Platelet, Plasma, RBC + Auto PAS Set
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Terumo BCT, Inc. 10811 West Collins Avenue, Lakewood, Colorado, USA Mfd. By: TFB Manufacturing SRL - Cartago, Costa Rica
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USA
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17 November 2023
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17 November 2028
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CMDR-2023-02077
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Sotera Epidural Anesthesia Kit
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Henan Touren Medical Device Co., Ltd. Weiyuan Industrial Zone Menggang, Changyuan County, 453400 Henan, People's Republic of China
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China
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21 November 2023
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21 November 2028
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CMDR-2023-02078
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Renasys Foam Dressing Kit with Soft Port
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Smith & Nephew Medical Limited 101 Hessle Road, Hull HU3 2BN, England Mfd. By: Viant Medical Inc. - 620 Watson SW, Grand Rapids, Michigan 49504, USA
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England
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17 November 2023
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17 November 2028
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CMDR-2023-02079A
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Through & Pass® Tube Stent Delivery System
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Forte Grow Medical Co., Ltd. 1647, Ohashi-cho, Sano-shi, Tochlgi, 327-0003 Japan Mfd. By: Forte Grow Medical (Vietnam) Co., Ltd. - 20 Tu Do Blvd., Vietnam-Singapore, Industrial Park, (VSIP), Thuan An Town, Binh Duong Province, Vietnam
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Japan
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21 November 2023
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21 November 2028
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CMDR-2023-02079B
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Through & Pass® Tube Stent Delivery System
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Forte Grow Medical Co., Ltd. 1647, Ohashi-cho, Sano-shi, Tochlgi, 327-0003 Japan Mfd. By: Forte Grow Medical (Vietnam) Co., Ltd. - 20 Tu Do Blvd., Vietnam-Singapore, Industrial Park, (VSIP), Thuan An Town, Binh Duong Province, Vietnam
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Japan
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21 November 2023
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21 November 2028
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CMDR-2023-02079C
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Through & Pass® Tube Stent Delivery System
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Forte Grow Medical Co., Ltd. 1647, Ohashi-cho, Sano-shi, Tochlgi, 327-0003 Japan Mfd. By: Forte Grow Medical (Vietnam) Co., Ltd. - 20 Tu Do Blvd., Vietnam-Singapore, Industrial Park, (VSIP), Thuan An Town, Binh Duong Province, Vietnam
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Japan
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21 November 2023
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21 November 2028
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CMDR-2023-02079D
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Through & Pass® Tube Stent Delivery System
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Forte Grow Medical Co., Ltd. 1647, Ohashi-cho, Sano-shi, Tochlgi, 327-0003 Japan Mfd. By: Forte Grow Medical (Vietnam) Co., Ltd. - 20 Tu Do Blvd., Vietnam-Singapore, Industrial Park, (VSIP), Thuan An Town, Binh Duong Province, Vietnam
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Japan
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21 November 2023
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21 November 2028
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CMDR-2023-02080A
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Manoscan ESO Catheter, SD Regular
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Given Imaging Inc. 15 Hampshire Street Manfield MA 02048, USA Mfd. By: Given Imaging Vietnam Co., Ltd. - Suite #6A, 6th Floor, Standard Factory Building, 14th Street, Tan Thuan EPZ, Tan Thuan Dong Ward, District 7, Ho Chi Minh City, Vietnam
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USA
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17 November 2023
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17 November 2028
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CMDR-2023-02080B
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ManoShield™ ESO SD Disposable Sanitary Sheath (for 2.75mm Diameter Catheters only)
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Given Imaging Inc. 15 Hampshire Street Manfield MA 02048, USA Mfd. By: Given Imaging Vietnam Co., Ltd. - Suite #6A, 6th Floor, Standard Factory Building, 14th Street, Tan Thuan EPZ, Tan Thuan Dong Ward, District 7, Ho Chi Minh City, Vietnam
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USA
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17 November 2023
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17 November 2028
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CMDR-2023-02081A
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Canack Disposable Breathing Circuit, Sterile
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Ningbo Luke Medical Devices Co., Ltd. Guyiayan, Yangming Road, 315400 Yuyao City, Zheiang Province, P.R. China
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China
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17 November 2023
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17 November 2028
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CMDR-2023-02081B
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Canack Disposable Breathing Circuit, Sterile
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Ningbo Luke Medical Devices Co., Ltd. Guyiayan, Yangming Road, 315400 Yuyao City, Zheiang Province, P.R. China
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China
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29 November 2023
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17 November 2028
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| View |
CMDR-2023-02082
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SafeCath™ Disposable Trocars, Balloon with Soft Anchor, Blunt Obturator
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Hangzhou Kangji Medical Instrument Co., Ltd. 1668 Chunjiang East Road, Economic Development Zone, Tonglu, Hangzhou, Zheijiang, 311501, China
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China
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17 November 2023
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17 November 2028
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CMDR-2023-02083
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Surgitech Disposable Trocar
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Microcure (Suzhou) Medical Technology Co., Ltd. 1-101, No. 188, Jialingjiang Road, 215000 Suzhou New District, Jiangsu P.R. China
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China
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17 November 2023
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17 November 2028
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CMDR-2023-02084A
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Trucath Foley Balloon Catheter, Silicone Coated, Without Catheter Plug
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Healthium Medtech Limited No. 472 D, 13th Cross, 4th Phase, Peenya Industrial Area, Bangalore, Karnataka - 560 058, India Mfd By: Sterimed Medical Devices Pvt. Ltd. Plot No. 211A, Sector - 16, HSIIDC, Bahadurgarh, 124507 Jhajjar Haryana, India
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India
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17 November 2023
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17 November 2028
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| View |
CMDR-2023-02084B
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Trucath Foley Balloon Catheter, Silicone Coated, With Catheter Plug
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Healthium Medtech Limited No. 472 D, 13th Cross, 4th Phase, Peenya Industrial Area, Bangalore, Karnataka - 560 058, India Mfd By: Sterimed Medical Devices Pvt. Ltd. Plot No. 211A, Sector - 16, HSIIDC, Bahadurgarh, 124507 Jhajjar Haryana, India
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India
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17 November 2023
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17 November 2028
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| View |
CMDR-2023-02084C
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Trucath Foley Balloon Catheter, Silicone Coated,2-way
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Healthium Medtech Limited No. 472 D, 13th Cross, 4th Phase, Peenya Industrial Area, Bangalore, Karnataka - 560 058, India Mfd By: Sterimed Medical Devices Pvt. Ltd. Plot No. 211A, Sector - 16, HSIIDC, Bahadurgarh, 124507 Jhajjar Haryana, India
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India
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17 November 2023
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17 November 2028
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| View |
CMDR-2023-02085
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BD Alaris™ Pump Infusion Blood Set 180 Micron Filter
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Becton Dickinson Holdings Pte. Ltd. 2 International Business Park Road, The Stategy #08-08, Singapore 609930 Mfd By: Sistemas Medicos Alaris SA de C.V. - Blvd. Insurgentes no. 20351, Parque Industrial, El Florido Section Vistas 1, Tijuan, Baja California, CP 22244, Mexico For: BD Switzerland Sarl - Route de Crassier 17 Business Park Terre-Bonn Batiment A4 1262 Eysins Switzerland
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Singapore
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17 November 2023
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17 November 2028
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CMDR-2023-02086
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ASAHI Peripheral Guidewire Gaia PV Pre-Shape
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Asahi Intecc Co., Ltd. 3-100 Akatsuki-cho, Seto-shi, Aichi, 489-0071 Japan Mfd. By: Asahi Intecc (Thailand) Co., Ltd. - 158/1 Moo 5, Bangkadi Industrial Park, Tiwanon Road, Tambol Bangkadi, Amphur Muang Pathumtahani, Pathumthani 12000, Thailand
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Japan
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17 November 2023
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17 November 2028
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CMDR-2023-02087A
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Straumann TLX RT Temporary, Abutment, for bridge, TAN
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Institut Straumann AG Peter-Merian-Weg 12 CH-4002 Basel, Switzerland Mfd By: Straumann Villeret SA - Les Champs du Clos 2, CH 2613 Villeret, Switzerland
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Switzerland
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17 November 2023
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17 November 2028
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