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CMDR-2022-00964B
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Vortran Go2Vent Automatic Gas-Powered Resuscitator
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Vortran Medical Technology 1, Inc. 21 Goldenland Court, Suite 100, Sacramento, California 95834, USA
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USA
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13 October 2022
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12 October 2027
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CMDR-2022-00965
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GGM Disposable Catheter Mount 22F Economic Double Swivel with Cap
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Great Group Medical Co. Ltd. #168 Xingong 2nd Rd., Tiazhong Township, Changhua County 52046, Taiwan R.O.C
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Taiwan
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04 October 2022
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04 October 2027
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CMDR-2022-00967
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Comen Ventilator
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Shenzhen Comen Medical Instruments Co., Ltd. Floor 10, Floor 11, and Section C of Floor 12 of Building 1A & floor 1 to Floor 5 of Building 2, FIYTA Timepiece Building Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen, Guangdong, 518106, P.R. China
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China
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04 October 2022
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04 October 2027
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CMDR-2022-00968
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Kanghui Posterior Medial Proximal Tibial Locking Compression Plate 3.5
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Changzhou Kanghui Medical Innovation Co., Ltd Address: No. 11, North Changjiang Road, Xinbei Zone 213022 Changzhou, Jiangsu P.R. China
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China
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04 October 2022
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04 October 2027
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CMDR-2022-00969
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VersaFlex Disposable pH Catheter Internal Reference Bifurcated, Single
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Given Imaging, Inc. 15 Hampshire St., MA, USA Mfd. By: Given Imaging Vietnam Co., Ltd Ho Chi Minh City, Vietnam for Covidien Pvt Ltd. - 50 Pasir Panjang Road, #04-51 Mapletree Business City, Singapore
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USA
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04 October 2022
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04 October 2027
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CMDR-2022-00970
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Kanghui Posterolateral Distal Tibial L Locking Compression Plate, 2.7
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Changzhou Kanghui Medical Innovation Co., Ltd Address: No. 11, North Changjiang Road, Xinbei Zone 213022 Changzhou, Jiangsu P.R. China
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China
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04 October 2022
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04 October 2027
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CMDR-2022-00971A
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INNOQ Disposable Ventilator Breathing Circuit
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Global SCP Medical Systems Pte. Ltd. 1 Kallang Junction, #05-01 Vanguard Campus, Singapore 339263 mfd. By: Excellentcare Medical (Huizhou) Ltd. - Shatou Industrial Zone, Yuanzhou Town, Boluo Country, Huizhou 516123 Guangdong, China
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Singapore
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05 October 2022
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05 October 2027
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CMDR-2022-00971B
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INNOQ Disposable Ventilator Breathing Circuit
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Global SCP Medical Systems Pte. Ltd. 1 Kallang Junction, #05-01 Vanguard Campus, Singapore 339263 mfd. By: Excellentcare Medical (Huizhou) Ltd. - Shatou Industrial Zone, Yuanzhou Town, Boluo Country, Huizhou 516123 Guangdong, China
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Singapore
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05 October 2022
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05 October 2027
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CMDR-2022-00972
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Medrad® Salient/Vistron 150 cm Y Extension Tube Dual Check Valve
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Bayer Medical Care B.V. Avenue Ceramique 27, 6221 KV Maastricht, The Netherlands Mfd. By: Vincent Medical (Dong Guan) Mfg.. Co. Ltd. - 45-46 ShaBu Industrial Zone Qiao Long District Tang Xia Town, Dong Guan City 523730 Guangdong Province, P.R. China Mfd. For: Imaxeon Pty. Ltd. - Unit 1, 38-46 South Street, Rydalmere, New South Wales 2116, Australia
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The Netherlands
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05 October 2022
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05 October 2027
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CMDR-2022-00973
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Sol-M™ Luer Lock Syringe with Exchangeable Needle
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Sol-Millennium Medical, Inc. No. 1735 North Brown Road, Suite 120, Lawrenceville, Georgia 30043, USA Mfd. By: Zhejiang Longde Pharmaceutical Co., Ltd. - No. 510 Shunfeng Road, Qianjiang Economic Development Zone, 311106, Hangzhou, Zhejiang, China
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China
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05 October 2022
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05 October 2027
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CMDR-2022-00974
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FARMASINO Disposable Syringe
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FarmaSino Pharmaceuticals (Jiangsu) Co., Ltd. Building 5, No. 9, Weidi Road 210033 Nanjing, Jiangsu Province, People's Republic of China
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China
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05 October 2022
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05 October 2027
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CMDR-2022-00975
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Signia™™ Small Diameter Reloads
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Covidien llc 15 Hampshire Street, Mansfield, MA 02048, USA Mfd. By Covidien 60 Middletown Avenue, North Haven, CT 06473, USA
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USA
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05 October 2022
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05 October 2027
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CMDR-2022-00976A
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Tri-Staple™ 2.0 Reinforced Intelligent Reload
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Covidien llc 15 Hampshire Street, Mansfield, MA 02048, USA Mfd. By Covidien 60 Middletown Avenue, North Haven, CT 06473, USA
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USA
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05 October 2022
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05 October 2027
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CMDR-2022-00976B
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Tri-Staple™ 2.0 Reinforced Intelligent Reload
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Covidien llc 15 Hampshire Street, Mansfield, MA 02048, USA Mfd. By Covidien 60 Middletown Avenue, North Haven, CT 06473, USA
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USA
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05 October 2022
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05 October 2027
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CMDR-2022-00977
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Shiley™ Adult Flexible Evac Tracheostomy Tube with Taperguard™ Cuff, Reusable Cannula
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Covidien llc 15 Hampshire Street, Mansfield, MA 02048, USA Mfd. By Covidien Cornamaddy - Co. Westmeath Athlone, Ireland
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USA
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05 October 2022
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05 October 2027
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CMDR-2022-00978
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Durex Invisible Extra Sensitive Condom
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Reckitt Benckiser Healthcare (UK) Limited 103-105 Bath Road, Slough, Berkshire, SLI 3UH, United Kingdom Mfd. By: SSL Manufacturing (Thailand) Limited - Wellgrow Industrial Estate 100 Moo 5, Bangna Trad Rd. Km. 36 Bangsamak, Bangpakong, Chachengso 21480 Thailand
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United Kingdom
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05 October 2022
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05 October 2027
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CMDR-2022-00979
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RAMSTAR Medical Nebulizer Mask
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Zhejiang Yuantong Medical Appliances Co., Ltd. East Side of Xinqiao, Shuangxin Highway Xinshi Town, Deqing County Huzhou 313201 Zhejiang, China
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China
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05 October 2022
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05 October 2027
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CMDR-2022-00980
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Wego Extracorporeal Blood Circuit for blood Purification Equipment
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WEGO Healthcare (Shenzhen) Co., Ltd. Unit 2503, East Technology Mansion, No. 16 Keyuan Road, Nanshan District, Shenzhen China Mfd. By: Weihai Weigao Blood Purification Products Co., Ltd. - No. 20 Xingshan, Shandong Province, People's Republic of China
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China
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05 October 2022
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05 October 2027
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CMDR-2022-00981A
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RSK Knee Prosthesis System - Femoral Condyle, PS Left
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Just Huajian Medical Device (Tianjin) Co., Ltd. No. 27 Ziyang Road, Nankai District, Tianjin, China PO 300190
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China
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05 October 2022
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05 October 2027
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CMDR-2022-00981B
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RSK Knee Prosthesis System - Femoral Condyle, PS Right
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Just Huajian Medical Device (Tianjin) Co., Ltd. No. 27 Ziyang Road, Nankai District, Tianjin, China PO 300190
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China
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05 October 2022
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05 October 2027
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