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CMDR-2022-00548C
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Arrow-Trerotola™ 5 Fr. X 65cm PTD® Set (Percutaneous Thrombolytic Device)
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Arrow International, Inc. - Reading, PA, USA mfd. By: Arrow Internacional de Chihuahua S.A. De C.V. - Chihuahua, Mexico
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Mexico
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05 May 2022
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05 May 2027
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CMDR-2022-00548D
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Arrow-Trerotola™ PTD® Rotator Drive Unite
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Arrow International, Inc. - Reading, PA, USA mfd. By: Arrow Internacional de Chihuahua S.A. De C.V. - Chihuahua, Mexico
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Mexico
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05 May 2022
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05 May 2027
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CMDR-2022-00548E
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Arrow-Trerotola™ Over-the-Wire PTD® Rotator Drive Unite
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Arrow International, Inc. - Reading, PA, USA mfd. By: Arrow Internacional de Chihuahua S.A. De C.V. - Chihuahua, Mexico
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Mexico
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05 May 2022
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05 May 2027
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CMDR-2022-00548F
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Arrow-Trerotola™ Over-the-Wire PTD® (Percutaneous Thrombolytic Device)
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Arrow International, Inc. - Reading, PA, USA mfd. By: Arrow Internacional de Chihuahua S.A. De C.V. - Chihuahua, Mexico
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Mexico
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05 May 2022
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05 May 2027
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CMDR-2022-00549A
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CT Asphina Intraocular Lens
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Carl Zeiss Meditec AG - Jena, Germany Mfd. By: Carl Zeiss Meditec SAS - Perigny, France
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Germany
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06 June 2022
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06 June 2027
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CMDR-2022-00549B
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AT LISA TRI Intraocular Lens
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Carl Zeiss Meditec AG - Jena, Germany Mfd. By: Carl Zeiss Meditec SAS - Perigny, France
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Germany
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06 June 2022
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06 June 2027
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CMDR-2022-00550
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Penumbra System Max 3Max Reperfusion Catheter
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Penumbra, Inc. One Penumbra Place, alameda, CA 94502, USA
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USA
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22 June 2022
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22 June 2027
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CMDR-2022-00553A
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EGIS Biliary Single Covered Stent
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S&G Biotech Inc. - 82, Bugok-Ro, pogok-EUP, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea
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Korea
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26 April 2022
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26 April 2027
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CMDR-2022-00553B
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EGIS Biliary Double Bare Stent
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S&G Biotech Inc. - 82, Bugok-Ro, pogok-EUP, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea
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Korea
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26 April 2022
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26 April 2027
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CMDR-2022-00554
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Hanarostent® Plumber™ Biliary (CCC) Stent
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M.I. Tech Co., Ltd. 174 Habuk 2-gil, Jinwi-myeon, Pyeontaek-si, Gyeonggi-do, 17706, South Korea
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South Korea
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15 November 2022
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29 April 2027
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CMDR-2022-00557
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Healen PRO Sodium Hyaluronic Pphthalmic Viscoelastic Device
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Amo Uppsala AB- Rapsgatan, 75136 Uppsala, Sweden
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SWEDEN
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08 July 2022
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08 July 2027
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CMDR-2022-00558A
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Bruner Syringe Arterial Blood Gas Sampler with Safety Needle
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Hubei Meteromega Technology LTD 1F Bldg. 3, Biomedical Industrial Park, Jiangqui 5th Road, Duodao District, Jingmen City, Hubei Province P.R. China
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China
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19 May 2022
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19 May 2027
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CMDR-2022-00558B
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Bruner Syringe Arterial Blood Gas Sampler
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Hubei Meteromega TEchnology LTD 1F Bldg. 3, Biomedical Industrial Park, Jianqiu 5th Road, Duodao District, Jingmen City, Hubei Province P.R. China
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China
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19 May 2022
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19 May 2027
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CMDR-2022-00560
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ACD-A Solution
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Fresenius Kaabi AB 61346 Bad Homburg Germany Mfd By: Fresenius Kabi Horatev CZ s.r.o - 104, 289 13 Horatev, Czech Republic
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Germany
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29 June 2022
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29 June 2027
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CMDR-2022-00561A
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ASAHI Gladius MG14 ASAHI PTCA Guide Wire (Pre-Shape)
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Asahi Intecc Co., Ltd. - 1703 Wakita- cho, Moriyama-ku, Nagoya, Aichi 463-0024, Japan Mfd. By: Asahi Intecc (Thailand) Co., Ltd. - 158/1 M005 Bangkadi Industrial Park, Tiwanon Road, Tambol Bangkadi, Amphur Muang Pathumthani, Pathumthani 1200, Thailand
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Japan
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07 July 2022
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07 July 2027
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CMDR-2022-00561B
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ASAHI Gladius MG14 ES ASAHI PTCA Guide Wire (Straight)
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Asahi Intecc Co., Ltd. - 1703 Wakita- cho, Moriyama-ku, Nagoya, Aichi 463-0024, Japan Mfd. By: Asahi Intecc (Thailand) Co., Ltd. - 158/1 M005 Bangkadi Industrial Park, Tiwanon Road, Tambol Bangkadi, Amphur Muang Pathumthani, Pathumthani 1200, Thailand
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Japan
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07 July 2022
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07 July 2027
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CMDR-2022-00561C
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ASAHI Gladius MG14 ES ASAHI PTCA Guide Wire (ES, Pre-Shape)
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Asahi Intecc Co., Ltd. - 1703 Wakita- cho, Moriyama-ku, Nagoya, Aichi 463-0024, Japan Mfd. By: Asahi Intecc (Thailand) Co., Ltd. - 158/1 M005 Bangkadi Industrial Park, Tiwanon Road, Tambol Bangkadi, Amphur Muang Pathumthani, Pathumthani 1200, Thailand
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Japan
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07 July 2022
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07 July 2027
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CMDR-2022-00561D
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ASAHI Gladius MG14 ASAHI PTCA Guide Wire (ES, Straight)
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Asahi Intecc Co., Ltd. - 1703 Wakita- cho, Moriyama-ku, Nagoya, Aichi 463-0024, Japan Mfd. By: Asahi Intecc (Thailand) Co., Ltd. - 158/1 M005 Bangkadi Industrial Park, Tiwanon Road, Tambol Bangkadi, Amphur Muang Pathumthani, Pathumthani 1200, Thailand
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Japan
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07 July 2022
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07 July 2027
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CMDR-2022-00561E
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ASAHI Gladius EX14 ASAHI PTCA Guide Wire (EX, Pre-Shape)
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Asahi Intecc Co., Ltd. - 1703 Wakita- cho, Moriyama-ku, Nagoya, Aichi 463-0024, Japan Mfd. By: Asahi Intecc (Thailand) Co., Ltd. - 158/1 M005 Bangkadi Industrial Park, Tiwanon Road, Tambol Bangkadi, Amphur Muang Pathumthani, Pathumthani 1200, Thailand
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Japan
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07 July 2022
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07 July 2027
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CMDR-2022-00561F
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ASAHI Gladius EX14 ASAHI PTCA Guide Wire (EX, Straight)
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Asahi Intecc Co., Ltd. - 1703 Wakita- cho, Moriyama-ku, Nagoya, Aichi 463-0024, Japan Mfd. By: Asahi Intecc (Thailand) Co., Ltd. - 158/1 M005 Bangkadi Industrial Park, Tiwanon Road, Tambol Bangkadi, Amphur Muang Pathumthani, Pathumthani 1200, Thailand
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Japan
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07 July 2022
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07 July 2027
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