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MDR-10105E
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HANAROSTENT® DUODENUM/PYLORUS KIM'S FLARE (NCN) DPDL STENT
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M.I. Tech Co., Ltd.
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Republic of Korea
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30 July 2020
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30 July 2021
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MDR-10105F
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HANAROSTENT® DUODENUM/PYLORUS (NCN) TLD STENT
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M.I. Tech Co., Ltd.
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Republic of Korea
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30 July 2020
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30 July 2021
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MDR-10106
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PRIMARY BLOOD SET 200 MICRON FILTER, SECURE LOCK
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ICU Medical , Inc. - IL, USA mfd. By: ICU Medcical Costa Rica, Ltd. - Heredia, Costa Rica
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Costa Rica
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24 September 2021
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30 July 2026
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MDR-10107
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PRIMARY MICRODRIP™ 150mL BURETTE SET WITH FLOAT VALVE, PREPIERCED ADDITIVE PORT, 15 MICRON FILTER IN SIGHT CHAMBER, PREPIERCED Y-SITE, SECURE LOCK 198cm/ 13mL
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ICU Medical , Inc. - IL, USA mfd. By: ICU Medcical Costa Rica, Ltd. - Heredia, Costa Rica
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Costa Rica
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24 September 2021
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30 July 2026
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MDR-10108
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PRIMARY Y-TYPE BLOOD SET 200 MICRON FILTER, CYLINDER PUMP, CONVERTIBLE PUMP, CONVERTIBLE PIN AND NON-VENTED PIN, SECURE LOCK 203cm/94mL
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ICU Medical, Inc. - IL, USA mfd. By: ICU Medical Costa Rica Ltd. - Heredia, Costa Rica
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Costa Rica
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07 October 2021
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30 July 2026
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MDR-10109
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PANAPORE PLASTIC SURGICAL TAPE
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Ningbo Greetmed Medical Instruments Co., Ltd.
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China
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30 July 2020
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30 July 2021
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MDR-10110
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PANAPORE PAPER SURGICAL TAPE
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Ningbo Greetmed Medical Instruments Co., Ltd.
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China
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30 July 2020
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30 July 2021
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MDR-10111
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RENASENZ AV FISTULA NEEDLE
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Jiangxi Hongda Medical Equipment Group Ltd.
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China
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30 July 2020
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30 July 2021
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MDR-10112
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Artisan Aphakia 5/8.5 PMMa, Iris Fixated, Pahakia Intraocular Lens
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Ophtec B.V - Schweitzerlaan 15 9728 NR, Groningen, The Netherlands
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The Netherlands
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30 March 2022
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20 July 2026
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MDR-10113A
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JMS INFUSION EXTENSION LINE - PLANECTA 1PORT
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JMS Healthcare Phl., Inc.
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Philippines
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30 July 2020
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30 July 2021
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MDR-10113B
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JMS INFUSION EXTENSION LINE - PLANECTA 2PORTS
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JMS Healthcare Phl., Inc.
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Philippines
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30 July 2020
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30 July 2021
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MDR-10113C
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JMS INFUSION EXTENSION LINE - PLANECTA 3PORTS
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JMS Healthcare Phl., Inc.
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Philippines
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30 July 2020
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30 July 2021
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MDR-10113D
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JMS INFUSION EXTENSION LINE - STOPCOCK WITH PLANECTA
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JMS Healthcare Phl., Inc.
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Philippines
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30 July 2020
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30 July 2021
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MDR-10114A
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CANACK 2-WAY SILICONE FOLEY CATHETER
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Ningbo Luke Medical Devices Co., Ltd.
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China
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30 July 2020
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30 July 2021
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MDR-10114B
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CANACK 3-WAY SILICONE FOLEY CATHETER
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Ningbo Luke Medical Devices Co., Ltd.
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China
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30 July 2020
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30 July 2021
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MDR-10115A
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DISPOSABLE NEUTRAL ELECTRODES (CAUTERY PADS)
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Zhejiang Jinhua Huatong Medical Appliance Co. Ltd.
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China
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30 July 2020
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30 July 2021
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MDR-10115B
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Disposable Neutral Electrodes (Cautery Pads) with Rem Cable
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Zhejiang Jinhua Huatong Medical Appliance Co., Ltd.- Jinhua, Zhejiang, China
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China
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17 March 2022
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20 July 2026
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MDR-10116
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MAXCHAMP BLACK NITRILE POWDER FREE MEDICAL EXAMINATION GLOVES, NON-STERILE
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Master Glove Manufacturing Sdn. Bhd.
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Malaysia
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30 July 2020
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30 July 2021
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MDR-10117A
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22MM COMPACT, EXTENDABLE BREATHING SYSTEM WITH 3L BAG AND 1.5 LIMB, 2.0M
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Intersurgical Ltd. - Berkshire, United Kingdom
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United Kingdom
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13 December 2021
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30 July 2026
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MDR-10117B
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22MM COMPACT, EXTENDABLE BREATHING SYSTEM WITH 2L BAG AND 1.5 LIMB, 2.0M
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Intersurgical Ltd. - Berkshire, United Kingdom
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United Kingdom
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13 December 2021
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30 July 2026
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