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MDR-10431A
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Zimede Ortho Distal Clavicle Lock Plate
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Suzhou Sunan Zimmered Medical Instrument Co., Ltd - Kunlunshan Road, Hexing, Zhangjiagang, Jiangsu Province, China Mfd. By: Suzhou Sunan Zimmered Medical Instrument Co., Ltd. - South Jiankang Road, Hexing, Jinfeng Town, Zhangjiagang, 215626 Jiangsu, P.R. China
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China
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30 August 2022
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25 September 2026
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MDR-10431B
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Zimede Ortho Proximal Tibia Lateral Locking Plate
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Suzhou Sunan Zimmered Medical Instrument Co., Ltd - Kunlunshan Road, Hexing, Zhangjiagang, Jiangsu Province, China Mfd. By: Suzhou Sunan Zimmered Medical Instrument Co., Ltd. - South Jiankang Road, Hexing, Jinfeng Town, Zhangjiagang, 215626 Jiangsu, P.R. China
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China
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30 August 2022
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25 September 2026
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MDR-10431C
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Zimede Ortho LC-DCP Tibial
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Suzhou Sunan Zimmered Medical Instrument Co., Ltd - Kunlunshan Road, Hexing, Zhangjiagang, Jiangsu Province, China Mfd. By: Suzhou Sunan Zimmered Medical Instrument Co., Ltd. - South Jiankang Road, Hexing, Jinfeng Town, Zhangjiagang, 215626 Jiangsu, P.R. China
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China
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30 August 2022
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25 September 2026
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MDR-10431D
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Zimede Ortho Distal Tibia Medial Locking Plate
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Suzhou Sunan Zimmered Medical Instrument Co., Ltd - Kunlunshan Road, Hexing, Zhangjiagang, Jiangsu Province, China Mfd. By: Suzhou Sunan Zimmered Medical Instrument Co., Ltd. - South Jiankang Road, Hexing, Jinfeng Town, Zhangjiagang, 215626 Jiangsu, P.R. China
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China
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30 August 2022
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25 September 2026
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MDR-10431E
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Zimede Ortho Distal Fibula Locking Plate
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Suzhou Sunan Zimmered Medical Instrument Co., Ltd - Kunlunshan Road, Hexing, Zhangjiagang, Jiangsu Province, China Mfd. By: Suzhou Sunan Zimmered Medical Instrument Co., Ltd. - South Jiankang Road, Hexing, Jinfeng Town, Zhangjiagang, 215626 Jiangsu, P.R. China
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China
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30 August 2022
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25 September 2026
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MDR-10431F
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Zimede Ortho Upper Limb Plate (Mini DCP)
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Suzhou Sunan Zimmered Medical Instrument Co., Ltd - Kunlunshan Road, Hexing, Zhangjiagang, Jiangsu Province, China Mfd. By: Suzhou Sunan Zimmered Medical Instrument Co., Ltd. - South Jiankang Road, Hexing, Jinfeng Town, Zhangjiagang, 215626 Jiangsu, P.R. China
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China
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30 August 2022
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25 September 2026
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MDR-10431G
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Zimede Ortho Multi-Direction Radius Distal Locking Plate
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Suzhou Sunan Zimmered Medical Instrument Co., Ltd - Kunlunshan Road, Hexing, Zhangjiagang, Jiangsu Province, China Mfd. By: Suzhou Sunan Zimmered Medical Instrument Co., Ltd. - South Jiankang Road, Hexing, Jinfeng Town, Zhangjiagang, 215626 Jiangsu, P.R. China
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China
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30 August 2022
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25 September 2026
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| View |
MDR-10432A
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CHASE MEDICAL SHUNT (TAPERED TIP)
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Chase Medical
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USA
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22 September 2020
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22 September 2021
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| View |
MDR-10432B
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CHASE MEDICAL SHUNT (BULB TIP)
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Chase Medical
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USA
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22 September 2020
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22 September 2021
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MDR-10438A
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Percutaneous Transluminal Coronary Angioplasty (PTCA) Guide Wire Sterilized Product (TYPE A) Code: ASAHI PTCA Guidewire ASAHI SION AH14R001SRJP
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Asahi Intecc Co., Ltd.-3-100 Akatsuki-cho, Seto-shi, Aichi, Japan Toyoflex Cebu Corporation-Lot 14, Block 2, Cebu Light Industrial Park (CLIP) Basak, 6015, Lapu-Lapu City
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Japan
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08 February 2022
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05 October 2026
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| View |
MDR-10438B
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Percutaneous Transluminal Coronary Angioplasty (PTCA) Guide Wire Sterilized Product (TYPE A) Code: ASAHI PTCA Guidewire ASAHI SION 190cm AH14R101SRJP
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Asahi Intecc Co., Ltd.-3-100 Akatsuki-cho, Seto-shi, Aichi, Japan Toyoflex Cebu Corporation-Lot 14, Block 2, Cebu Light Industrial Park (CLIP) Basak, 6015, Lapu-Lapu City
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Japan
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08 February 2022
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05 October 2026
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| View |
MDR-10438C
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Percutaneous Transluminal Coronary Angioplasty (PTCA) Guide Wire Sterilized Product (TYPE A) Code: ASAHI PTCA Guidewire ASAHI SION Blue AH14R004SR JP
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Asahi Intecc Co., Ltd.-3-100 Akatsuki-cho, Seto-shi, Aichi, Japan Toyoflex Cebu Corporation-Lot 14, Block 2, Cebu Light Industrial Park (CLIP) Basak, 6015, Lapu-Lapu City
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Japan
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08 February 2022
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05 October 2026
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| View |
MDR-10438D
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Percutaneous Transluminal Coronary Angioplasty (PTCA) Guide Wire Sterilized Product (TYPE A) Code: ASAHI PTCA Guidewire ASAHI SION Blue 190cm AH14R104SR JP
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Asahi Intecc Co., Ltd.-3-100 Akatsuki-cho, Seto-shi, Aichi, Japan Toyoflex Cebu Corporation-Lot 14, Block 2, Cebu Light Industrial Park (CLIP) Basak, 6015, Lapu-Lapu City
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Japan
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08 February 2022
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05 October 2026
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| View |
MDR-10439A
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Percutaneous Transluminal Coronary Angioplasty (PTCA) Guide Wire Sterilized Product (TYPE A) Code: X-treme XT-A A0419-01PSR JP
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Asahi Intecc Co., Ltd.- Aichi, Japan Mfd By: Toyoflex Cebu Corporation-Lot 14 Block 2, Cebu Light Insdustrial Park (CLIP), Basak, Lapu-Lapu City
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Japan
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08 February 2022
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05 October 2026
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| View |
MDR-10439B
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Percutaneous Transluminal Coronary Angioplasty (PTCA) Guide Wire Sterilized Product (TYPE A) Code: X-treme XT-R R0419-Z6PSR JP
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Asahi Intecc Co., Ltd.- Aichi, Japan Mfd By: Toyoflex Cebu Corporation-Lot 14 Block 2, Cebu Light Insdustrial Park (CLIP), Basak, Lapu-Lapu City
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Japan
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08 February 2022
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05 October 2026
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MDR-10445
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Dideco Perfusion Tubing Systems CP84524IT Cardiopulmonary Bypass System Tubing Set
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Sorin Group Italia S.r.l - Via Benigno Crespi 17, 20159, Milan, Italy Mfd. By: Sorin Group Italia S.r.l - Via Statale 12 Nord, 86 41037 Mirandola MO, Italy
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Italy
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27 June 2022
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05 October 2026
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MDR-10451
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Unite Coronary Angiography (CAG) Catheter, NS
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Asahi Intecc Co., Ltd.- Aichi, Japan Mfd By: Toyoflex Cebu Corpoation-Lot 14, Block 2, Cebu Light Industrial Park (CLIP), Basak, 6015, Lapu-Lapu City
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Japan
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08 February 2022
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05 October 2026
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| View |
MDR-10454A
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MATEREGEN GEL INTRAUTERINE ADHESION BARRIER GEL
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ME & H Inc. - GF, Bundang posvill officiete #723, 51 Seongnam-draco, Bundang-gu, Seongnam-Si, Gyeonggi-do, Korea, mfd. By: BioRegen Biomedical (Changzhou) co., Ltd. - Changzhou, Jiangsu, China
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China
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05 October 2020
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05 October 2020
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MDR-10454B
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MATEREGEN GEL INTRAUTERINE ADHESION BARRIER GEL WITH INJECTION CANNULA
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ME & H Inc. - GF, Bundang posvill officiete #723, 51 Seongnam-draco, Bundang-gu, Seongnam-Si, Gyeonggi-do, Korea, mfd. By: BioRegen Biomedical (Changzhou) co., Ltd. - Changzhou, Jiangsu, China
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China
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05 October 2020
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05 October 2020
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MDR-10455A
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ULTRA V HIKO (Cannula) Sterile Single Use PDO (Polydioxanone) Suture with Needle
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Ultra V Co., Ltd. #804, Shin-Han IT Tower, 19 Snagwon-gil, Seongdong-gu,Seoul, Korea Mfd. By: 21 Century Medical Co., Ltd. - 32, Jungga-ro, Buk-gu, Gwangju, Korea
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Korea
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18 January 2023
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05 October 2026
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