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MDR-10960D
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DxTerity™ TRA Catheter Angio-Kit Radial, TRApease, 145° Pigtail
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Medtronic International trading Pte. Ltd. 50 Pasir Panjang Road, #04-51, Mapletree Business City, Singapore 117384 Mfd. By: Availmeed S.A. de C.V. - C. Industrial Lt. 001 Mz. 105 No. 20905 Int. A, Col. Cd. Industrial, Tijuana, Baja California, C.P. 22444, Mexico, For: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432, USA
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Singapore
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07 October 2022
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13 September 2027
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MDR-10963A
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PUREREGEN GEL ENT NASAL AND OTOLOGIC DRESSING
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M & H Inc. - Seongnam-Si, Gyeonggi-do, Korea mfd. By: BioRegen Biomedical (Changzhou) Co., Ltd. - Changzhou, Jiangsu, China
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China
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21 September 2021
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21 September 2022
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MDR-10963B
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PUREREGEN GEL OTOL OTOLOGIC DRESSING
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M & H Inc. - Seongnam-Si, Gyeonggi-do, Korea mfd. By: BioRegen Biomedical (Changzhou) Co., Ltd. - Changzhou, Jiangsu, China
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China
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21 September 2021
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21 September 2022
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MDR-10963C
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PUREREGEN GEL SINUS NASAL AND SINUS DRESSING
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M & H Inc. - Seongnam-Si, Gyeonggi-do, Korea mfd. By: BioRegen Biomedical (Changzhou) Co., Ltd. - Changzhou, Jiangsu, China
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China
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21 September 2021
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21 September 2022
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MDR-10964
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MISTI Nasal Implant Premium Swan
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Keosan Trading Co., #805-806 Human teco B/D, 57 Achasan-ro 17-gil, Seongdong-gu, Seoul, Korea
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Korea
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01 February 2023
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30 September 2027
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MDR-10965
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INNOQ POWDER FREE LATEX EXAMINATION GLOVES
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Global SCP Medical Systems Pte. Ltd. ("Global SCP") - Teletech Park, Singapore mfd. By: Professional Latex Sdn. Bhd. - Perak Darul Ridzuan, Malaysia
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Malaysia
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24 November 2021
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24 November 2022
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MDR-10966
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Mericron XL™ Non-Absorbable Poly (Ethylene Terephthalate) Surgical U.S.P. (Synthetic) Sterilized Surgical Needled Suture (Braided Coated Polyester White/Green)
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Meril Endo Pvt. Ltd. Third Floor, E1-E3, Meril Park, Survey no. 135/2/B & 174/2, Muktanand Marg, Chala, 396191 Vapi, Gujarat, India
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India
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12 October 2022
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24 November 2027
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MDR-10966A
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Straumann® Loxim™ SLA Bone Level Implant, Narrow Crossfit, Titanium
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Institut Straumann AG - Peter Merian-Weg 12, 4002 Basel. Switzerland Mfd. By: Straumann Villeret SA - Les Champs du Clos 2, 2613 Villeret Switzerland
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Switzerland
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14 July 2022
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14 July 2023
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MDR-10966B
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Straumann® Loxim™ SLA Bone Level Implant, Regular Crossfit, Titanium
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Institut Straumann AG - Peter Merian-Weg 12, 4002 Basel. Switzerland Mfd. By: Straumann Villeret SA - Les Champs du Clos 2, 2613 Villeret Switzerland
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Switzerland
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14 July 2022
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14 July 2023
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MDR-10967
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Tapered Screw-Vent Implant System Abutment, Gold, Engaging
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Biomet 3i, LLC 4555 Riverside Dr Palm Beach Gardens Florida, USA Mfd. By: Biomet 3i Dental Iberica, S.L.U - C/ Islas Baleares, 50, Pol, Ind. Fuente del Jarro, Paterna, Valencia, 46988, Spain For: Zimmer Dental Inc. - 1900 Aston Avenue, Carlsbad, CA 92008, USA
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USA
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25 October 2022
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15 November 2027
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MDR-10968A
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TRIVA-AAY ACRYLIC ASPHERIC TRIFOCAL DIFFRACTIVE YELLOW INTRAOCULAR LENS
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HumanOptics AG - Erlangen, Germany
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Germany
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15 November 2021
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15 November 2022
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MDR-10968B
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TRIVA-AAY SAFELOADER ACRYLIC ASPHERIC TRIFOCAL DIFFRACTIVE YELLOW INTRAOCULAR LENS
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HumanOptics AG - Erlangen, Germany
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Germany
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15 November 2021
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15 November 2022
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MDR-10969
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TSV HEALING COLLAR ABUTMENT
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Zimmer Dental, Inc. - Carlsbad, CA, USA mfd. By: Biomet 3i Dental Iberica, S.LU.c - Valencia, Spain
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Spain
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07 December 2021
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07 December 2022
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MDR-10970
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ARROW® MULTI-LUMEN CENTRAL VENOUS CATHERIZATION SET WITH BLUE FLEX TIP® CATHETER
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Teleflex Medical - Westmeath, Ireland mfd. By: Arrow International de Chihuahua S.A. de C.V. - Chihuahua, CP, Mexico For:Arrow International, Inc. (subsidiary of Teleflex Incorporated) - Reading, Pennysylvania, USA
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USA
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07 December 2021
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07 December 2022
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MDR-10971
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Dynarex Surgical Sponges, All Gauze, U.S.P. Type Vii, Sterile
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Dynarex Corporation 10 Glenshaw St., Orangeburg, New York, USA Mfd. By: Allmed Medical Products Co., Ltd. No. 18 Qixing Road, Majiadian Town 443200 Zhijiang City, Hubei Province, People's Republic of China
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China
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28 February 2023
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07 December 2027
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MDR-10972
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Dynarex Lap Sponges, Pre-washed, X-ray Detectable, Sterile
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Dynarex Corporation 10 Glenshaw St., Orangeburg, New York, USA Mfd. By: Allmed Medical Products Co., Ltd. No. 18 Qixing Road, Majiadian Town 443200 Zhijiang City, Hubei Province, People's Republic of China
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China
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28 February 2023
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07 December 2027
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MDR-10972A
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FIAB Sterile Disposable Hand Switch Pencil (Electrosurgical)
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FIAB S.p.A - Vicchio (FI), Italy
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Italy
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17 March 2022
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09 February 2027
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MDR-10972B
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FIAB Sterile Disposable Hand Switch Pencil with Antisticking Standard Blade (Teflon) (Electrosurgical)
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FIAB S.p.A - Vicchio (FI), Italy
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Italy
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17 March 2022
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09 February 2027
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MDR-10973
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ARROW+GARD BLUE TWO LUMEN HEMODIALYSIS CATHETERIZATION SET WITH BLUE FLEXTIP, CURVED CATHETER FOR HIGH VOLUME INFUSIONS
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Teleflex Medical - Westmeath, Ireland mfd. By: Arrow International de Chihuahua S.A. de C.V. - Chihuahua, Mexico For: Arrow International, Inc. - Reading, PA, USA
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USA
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07 December 2021
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07 December 2022
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MDR-10974
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ARROW+GARD BLUE TWO LUMEN HEMODIALYSIS CATHETERIZATION SET WITH BLUE FLEXTIP, CURVED CATHETER FOR HIGH VOLUME INFUSIONS
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Teleflex Medical - Westmeath, Ireland mfd. By: Arrow International de CR a.s. Jamaska - Sazavou, Czech Republic For: Arrow International, Inc. - Reading, PA, USA
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USA
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07 December 2021
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07 December 2022
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