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MDR-09378A
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EXCELENS® INTRAOCULAR LENS, PMMA RIGID SINGLE PIECE POSTERIOR CHAMBER C LOOP
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Excel Optics (P) Limited - Tamil Nadu, India
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India
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22 January 2021
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25 March 2026
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MDR-09378B
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EXCELENS® INTRAOCULAR LENS, PMMA RIGID SINGLE PIECE POSTERIOR CHAMBER MODIFIED C LOOP
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Excel Optics (P) Limited - Tamil Nadu, India
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India
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22 January 2021
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25 March 2026
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MDR-09378C
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EXCELENS® INTRAOCULAR LENS, PMMA RIGID SINGLE PIECE POSTERIOR CHAMBER S LOOP
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Excel Optics (P) Limited - Tamil Nadu, India
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India
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22 January 2021
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25 March 2026
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MDR-09389
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LIQUIBAND FIX8® OPEN HERNIA MESH FIXATION DEVICE
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Advanced Medical Solutions Limited - Plymouth, Devon, United Kingdom
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United Kingdom
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23 June 2021
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25 March 2026
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MDR-09390
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BEN-AIR SURGERY SA PM2 80K Burs Range, Stainless Steel, Sterile
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Bien-Air Surgery S.A - Le Noirmont, Switzerland
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Switzerland
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09 August 2022
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25 March 2026
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MDR-09394A
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BEN-AIR SURGERY SA PM2 80K Burs Range, Diamond
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Bien-Air Surgery S.A - Le Noirmont, Switzerland
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Switzerland
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09 August 2022
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25 March 2026
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MDR-09394B
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Bien-Air Surgery SA PM2 80K Burs Range, Coarse Diamond
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Bien-Air Surgery SA Rue de l'Ouest 2B, 2340 Le Noirmont Mfd By: Ben-Air Surgery SA - 1 Route de Soleure, Bienne/Bien, 2504 Switzerland
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Swintzerland
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25 January 2024
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25 March 2029
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MDR-09395
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ARROW® MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION SET BLUE FLEX TIP® ARROWG+ARD® BLUE CATHETER
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Teleflex Medical - Westmeath, Ireland mfd. By: Arrow International CR, a.s. - Jamska, Zdar Nad Sazavou, Czech Republic For International LLC (Subsidiary of Teleflex Incorporated) - North Carolina, USA
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USA
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28 May 2021
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25 March 2026
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MDR-09396
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TRUST™ CONDOM (BUBBLEGUM)
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NRS Global Partner Sdn. Bhd. - Kuala Lumpur, Malaysia mfd by: Innolatex Sdn. Bhd. - Selangor, Malaysia
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Malaysia
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25 March 2021
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25 March 2026
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MDR-09399
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SURE-GUARD® SAFETY INSULIN SYRINGE WITH RETRACTABLE NEEDLE
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Anhui Tiankang Medical Technology Co., Ltd. - Economic Development Zone, Tianchang City, Anhui, China
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China
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25 March 2021
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25 March 2026
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MDR-09400
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MIS CONICAL CONNECTION HEALING CAP, WIDE PLATFORM (WP)
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MIS Implants Technologies Ltd. - Bar Lev Industrial Park, 2015600, Israel
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Israel
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14 June 2021
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25 March 2026
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MDR-09401A
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NEODENT GM TITAMAX ACQUA IMPLANT
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Institut Straumann AG - Basel, Switzerland mfd. By: JJGC Industria e Comercio de Materiais Dentorias Cu - Paana, PR, Brazil
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Brazil
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02 August 2021
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07 April 2026
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MDR-09401B
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NEODENT GM DRIVE ACQUA IMPLANT
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Institut Straumann AG - Basel, Switzerland mfd. By: JJGC Industria e Comercio de Materiais Dentorias Cu - Paana, PR, Brazil
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Brazil
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02 August 2021
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07 April 2026
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MDR-09401C
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NEODENT GM HELIX ACQUA IMPLANT
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Institut Straumann AG - Basel, Switzerland mfd. By: JJGC Industria e Comercio de Materiais Dentorias Cu - Paana, PR, Brazil
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Brazil
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02 August 2021
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07 April 2026
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MDR-09406
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MINI 4 ASPHERIC MONOFOCAL INTRACULAR LENS
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SIFI S.p.A - S. Antonio, Catania, Italy
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Italy
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15 November 2021
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25 March 2026
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MDR-09407
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PROKERA® PLUS BIOLOGIC CORNERAL BANDAGE SELF-RETAINING CRYOPRESERVED HUMAN AMNIOTIC MEMBRANE
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Bio-Nutri Co., Ltd. - Tortola, British Virgin Island mfd. By: Tissuetech, doing business as Bio-Tissue, Inc. also doing business as Amniox Medical, Inc. - Doral, FL, USA For: Tissuetech, Inc. - also doing business as Bio Tissue, Inc. also doing business as Amniox Medical, Inc, - Miami, FL, USA
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USA
|
23 August 2021
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25 March 2026
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MDR-09408
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PROKERA® SLIM BIOLOGIC CORNEAL BANDAGE SELF-RETAINING CYROPRESERVED HUMAN AMNIOTIC MEMBRANE
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Bio-Nutri Co., Ltd. - British Virgin Island mfd. By: TissueTech, Inc. also dba as Bio-Tissue, Inc. - also dba as Amniox Medical, Inc. Miami, FL, USA
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USA
|
08 November 2021
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25 March 2026
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MDR-09409A
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EDWARDS LIFESCIENCES® PRESSURE MONITORING SET WITH TRUWAVE™ DISPOSABLE PRESSURE TRANSDUCER; Codes/Size: PX260, PX1X2, PX212, PX284, PX272
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Edwards Lifesciences (Thailand) Ltd. - Bangkok 10320, Thailand mfd. By: Edwards Lifesciences AG, Parque Industrial Itabo - San Cristobal, Dominican Republic For: Edwards Lifesciences LLC - Irvine, CA, USA
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USA
|
11 March 2021
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25 March 2026
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MDR-09409B
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EDWARDS LIFESCIENCES® PRESSURE MONITORING SET WITH TRUWAVE™ DISPOSABLE PRESSURE TRANSDUCER; Codes/Size: PX2X3, PX2X2
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Edwards Lifesciences (Thailand) Ltd. - Bangkok 10320, Thailand mfd. By: Edwards Lifesciences AG, Parque Industrial Itabo - San Cristobal, Dominican Republic For: Edwards Lifesciences LLC - Irvine, CA, USA
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USA
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11 March 2021
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25 March 2026
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MDR-09409C
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EDWARDS LIFESCIENCES® PRESSURE MONITORING SET WITH TRUWAVE™ DISPOSABLE PRESSURE TRANSDUCER; Codes/Size: PX3X3, PX3272
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Edwards Lifesciences (Thailand) Ltd. - Bangkok 10320, Thailand mfd. By: Edwards Lifesciences AG, Parque Industrial Itabo - San Cristobal, Dominican Republic For: Edwards Lifesciences LLC - Irvine, CA, USA
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USA
|
11 March 2021
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25 March 2026
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