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MDR-08596B
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PENUMBRA SMART COIL STANDARD
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Penumbra Inc. - Alameda, CA, USA
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USA
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29 October 2020
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02 September 2025
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MDR-08596C
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PENUMBRA SMART COIL SOFT
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Penumbra Inc. - Alameda, CA, USA
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USA
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29 October 2020
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02 September 2025
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MDR-08596D
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PENUMBRA SMART COIL EXTRA SOFT
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Penumbra Inc. - Alameda, CA, USA
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USA
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29 October 2020
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02 September 2025
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MDR-08596E
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PENUMBRA SMART COIL WAVE EXTRA SOFT
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Penumbra Inc. - Alameda, CA, USA
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USA
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29 October 2020
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02 September 2025
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MDR-08597
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TAEWOONG NITI-S BILIARY COVERED STENT (KAFFES) - ENDOSCOPIC
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Taewoong Medical Co. Ltd. - Gyeonggi-do, Korea
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Korea
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04 November 2020
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02 September 2025
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MDR-08598
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AESTHEFILL® FACIAL WRINKLE, FILLER
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Regen Biotech, Inc. - 1F, 20, Daehwa-ro, 139beongil, Daedeok-gu, Daejeon, Korea
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Korea
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12 May 2021
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02 September 2025
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MDR-08599A
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MIRUS™ LINEAR STAPLER WITH DIAL
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M/S Meril Endo Surgery Pvt. Ltd. - Gujarat, India
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India
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09 February 2021
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02 September 2025
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MDR-08599B
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MIRUS™ CARTRIDGES FOR MIRUS LINEAR STAPLER WITH DIAL
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M/S Meril Endo Surgery Pvt. Ltd. - Gujarat, India
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India
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09 February 2021
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02 September 2025
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MDR-08600
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AIRLIFE™ MISTY FAST™ SMALL VOLUME NEBULIZER WITH 7 FOOT (2.1m) CRUSH RESISTANT OXYGEN TUBING AND BAFFLED MOUTH PIECE
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Vyaire Medical Inc. - IL, USA mfd. By: Productos Urologos De Mexico S.A. De C.V. - Baja California, Mexico
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Mexico
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23 December 2020
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02 September 2025
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MDR-08601A
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AIRLIFE™ STERILE WATER FOR INHALATION, USP 2000mL
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Vyaire Medical Inc. - 26125 N. Riverwoods Blvd. Mettawa, IL, USA mfd. By: Laboratorios PiSa De C.V. - Jalisco, Mexico
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Mexico
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09 August 2021
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02 September 2025
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MDR-08601B
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AIRLIFE™ STERILE WATER FOR INHALATION, USP 1000mL
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Vyaire Medical Inc. - 26125 N. Riverwoods Blvd. Mettawa, IL, USA mfd. By: Laboratorios PiSa De C.V. - Jalisco, Mexico
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Mexico
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09 August 2021
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02 September 2025
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MDR-08602
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EDWARS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHERISIS (AORTIC)
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Edwards Lifesciences (Thailand) Ltd. - Bangkok, Thailand mfd. By: Edwards Lifesciences (Singapore) Pte. Ltd. - Changi, Singapore For: Edwards Lifesciences LLC- Irvine, CA, USA
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USA
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08 January 2021
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02 September 2025
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MDR-08603
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EDWARD LIFESCIENCES INSPIRIS™ RESILIA™ AORTIC VALVE
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Edward Lifesciences (Thailand) Ltd. - Bangkok, Thailand mfd. By: Edward Lifesciences LLC - Irvine, USA
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USA
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10 May 2021
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02 September 2025
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MDR-08604
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EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS (MITRAL)
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Edward Lifesciences (Thailand) Ltd. - Bangkok, Thailand mfd. By: Edward Lifesciences LLC - Irvine, USA
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USA
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10 May 2021
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30 July 2025
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MDR-08605
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UNIVERSAL PACK 1
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Medline Industries, Inc.
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China
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07 November 2019
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07 November 2020
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MDR-08606
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ISCALPEL™ ULTRASOUND ACTIVATED SCALPEL SYSTEM, SHEAR
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Hocer (Tianjin) Medical Technologies Co., Ltd.
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China
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02 September 2019
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02 September 2020
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MDR-08607
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CONVERTORS® TIBURON BILATERAL EXTREMITY DRAPE
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Cardinal Health 200 LLC
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USA
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02 September 2019
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02 September 2020
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MDR-08608
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SOLARE UNIVERSAL BONDING AGENT
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GC Asia Dental Pte. Ltd. - Singapore mfd. By: GC Dental Products Corporation - Aichi, Japan
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Japan
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22 January 2021
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02 September 2025
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MDR-08609A
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XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
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Abbott Vascular - Santa Clara, CA, USA mfd. By: Abbott Vascular - Clonmel, Tipperary, Ireland
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Ireland
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03 November 2020
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02 September 2025
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MDR-08609B
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XIENCE XPEDITION SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM
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Abbott Vascular - Santa Clara, CA, USA mfd. By: Abbott Vascular - Clonmel, Tipperary, Ireland
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Ireland
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03 November 2020
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02 September 2025
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