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MDR-10511B
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ENDURE POLYETHERSULFONE DIALYZER; Code: High Flux
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Farmasol Tibbi Urunler San. Ve Tic A.S. - Kayseri, Turkey
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Turkey
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20 October 2020
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20 October 2021
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MDR-10512A
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LNHX Hemodialysis Powder A
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Lianning Trustrong Biological Technology Co., Ltd. No. 15, 1 Secrion Longquan Road, Chaoyang Development Area, Chaoyang, 122005, Liaoning, P.R. China
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China
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23 May 2023
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20 October 2026
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MDR-10512B
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LNHX Hemodialysis Powder B
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Liaoning Trustrong Biological Co., Ltd. - No. 15, 1 Section Longquan road, Chaoyang Development Area, Chaoyang, 122005, Liaoning, P.R. China
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China
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22 August 2022
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20 October 2026
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MDR-10513A
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Bioteq Nasal Axygen Cannula (Green)
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Bioteque Medical Philippines Inc. - Block 14 Lots 2,3,4 Hermosa Ecozone Industrial Park, Brgy. Palihan, Hermosa, Bataan
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Philippines
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27 April 2022
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20 October 2026
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MDR-10513B
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BIOTEQ® NASAL OXYGEN CANNULA (TRANSPARENT)
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Bioteque Medical Phil., Inc. - Block 14, Lots 2,3,4, Hermosa Ecozone Industrial Park, Brgy. Palihan, Hermosa, Bataan
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Philippines
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20 October 2020
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20 October 2021
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MDR-10513C
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BIOTEQ Nasal Oxygen Cannula (Soft Tip)
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Bioteque Medical Philippines, Inc. - Block 14, Lots 2, 3, 4 Hermosa Ecozone Industrial Park, Brgy. Palihan, Hermosa, Bataan
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Philippines
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30 March 2022
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20 October 2026
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MDR-10513D
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BIOTEQ Nasal Oxygen Cannula (Soft Tip Transparent)
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Bioteque Medical Philippines, Inc. - Block 14, Lots 2, 3, 4 Hermosa Ecozone Industrial Park, Brgy. Palihan, Hermosa, Bataan
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Philippines
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30 March 2022
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20 October 2026
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MDR-10514
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Eco Disposable Microwave Therapeutic Antenna
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Nanjing ECO Microwave System Co., Ltd. 3F, Block 2; 1/3/4F, Block 4, No. 19, Xinghui Road, Jiangbei New District, 211500, Nanjing, Jiangsu, P.R. China
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China
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16 December 2022
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20 October 2022
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MDR-10515A
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ALPHA ORTHO-K ORTHOKERATOLOGY LENS (BLUE)
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Alpha Corporation Inc. - 1-8-16, Izumi, Higashi-ku, Nagoya-City, Aichi, 461-0001 Japan mfd. By: Alpha Corporation Inc. INA Branch Minamimikowa-Mura, Kamiina-Gumm Nagano Japan
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Japan
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20 October 2020
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20 October 2021
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MDR-10515B
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ALPHA ORTHO-K ORTHOKERATOLOGY LENS (CLEAR)
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Alpha Corporation Inc. - 1-8-16, Izumi, Higashi-ku, Nagoya-City, Aichi, 461-0001 Japan mfd. By: Alpha Corporation Inc. INA Branch Minamimikowa-Mura, Kamiina-Gumm Nagano Japan
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Japan
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20 October 2020
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20 October 2021
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MDR-10516A
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HYAREGEN GEL ABSORBABLE ADHESION BARRIER GEL
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ME & H Inc. - GF, Bundang posvill officiete #723, 51 Seongnam-draco, Bundang-gu, Seongnam-Si, Gyeonggi-do, Korea, mfd. By: BioRegen Biomedical (Changzhou) co., Ltd. - Changzhou, Jiangsu, China
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China
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05 October 2020
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05 October 2020
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MDR-10516B
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HYAREGEN GEL ABSORBABLE ADHESION BARRIER GEL WITH INJECTION CANNULA
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ME & H Inc. - GF, Bundang posvill officiete #723, 51 Seongnam-draco, Bundang-gu, Seongnam-Si, Gyeonggi-do, Korea, mfd. By: BioRegen Biomedical (Changzhou) co., Ltd. - Changzhou, Jiangsu, China
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China
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05 October 2020
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05 October 2020
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MDR-10517
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Ligaclip Endoscopic Rotating Multiple Clip Applier
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Ethicon Endo-Surgery, LLC - 475 Calle C, Guaynabo, Puerto Rico, 00969, USA Mfd. By: Ethicon Endo-Surgery S.A. De C.V. Planta II - Calle Durango No. 2751, Colonia Lote Bravo, 32575 Ciudad Juarez, Chihuahua, Mexico
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USA
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08 February 2022
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29 October 2026
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MDR-10518
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Echelon Endopath™ Endoscopic Linear Cutter Reloads
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Ethicon Endo-Surgery, LLC - 475 Calle C, Guaynabo, Puerto Rico, 00969, USA Mfd. By: Ethicon Endo-Surgery S.A. De C.V. Planta II - Calle Durango No. 2751, Colonia Lote Bravo, 32575 Ciudad Juarez, Chihuahua, Mexico
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USA
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08 February 2022
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29 October 2026
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MDR-10519
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KJ DISPOSABLE LIGATION CLIP (POLYMER)
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Hangzhou Kangji Medical Instruments Co., Ltd. - Hangzhou, Zhejiang, China
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China
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29 October 2020
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29 October 2021
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MDR-10520
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Vertex Sterile Disposable Pre-Filled Bubble Humidifier
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Star Medik Sdn. Bhd. No. 43, Jalan Tiara, Tiara Sentral 2, Nilai Utama Enterprise Park, 71800 Nilai, Negeri Sembilan, Malaysia
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Malaysia
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29 September 2022
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22 October 2026
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MDR-10521A
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Trauhui® Cottey MD Variable Angle Locking Plate System 3.5 Distal Lateral Tibia Plates, Left
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Jiangsu Trauhui Instrument Co., Ltd. No. 2 Longqing Rd., Wujin Hi-Tech Zone, 213168, Changzhou, Jiangsu, China
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China
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01 February 2023
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22 October 2026
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MDR-10521B
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Trauhui® Cottey MD Variable Angle Locking Plate System 3.5 Distal Lateral Tibia Plates, Right
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Jiangsu Trauhui Instrument Co., Ltd. No. 2 Longqing Rd., Wujin Hi-Tech Zone, 213168, Changzhou, Jiangsu, China
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China
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01 February 2023
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22 October 2026
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MDR-10522
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Glassycem Radiopaque Glass Ionomer Luting Cement
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Technodent Co. Ltd. Belgorod Region, Russia
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Russia
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16 June 2022
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22 October 2026
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MDR-10523
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Glassycem Radiopaque Glass Ionomer Restorative Cement
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Technodent Co. Ltd. 1/6 Beryozovaya Str., Severnyi, Belgorod Region, Russia
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Russia
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13 December 2022
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22 October 2026
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