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Date of Notification
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Title
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FSN
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31 Aug 2018
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Philips HeartStart M5072A Infant/Child SMART Pads Cartridge, Philips Medical Systems (HSA 600:41/01-026/18/24_37)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-18-24_37 FSN_Redacted361 KB
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31 Aug 2018
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ARCHITECT ICT Module, Abbott Laboratories (HSA 600:41/01-005/18/12_59)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com
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HSA 6004101-005-18-12_59 FSN278 KB
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31 Aug 2018
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Beckman Coulter Enzymatic Creatinine, Beckman Coulter HDL-Cholestrol, Beckman Coulter Lipase, Beckman Coulter Uric Acid, Beckman Coulter Inc (HSA 600:41/01-052/18/04_73)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 6340 7126
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HSA 60004101-052-18-04_73 FSN_Redacted150 KB
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31 Aug 2018
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Alinity s System, Abbott GmbH & Co. KG (HSA 600:41/01-005/18/13_31)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com
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HSA 6004101-005-18-13_31 FSN101 KB
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31 Aug 2018
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cobas e 411 analyzer, Roche Diagnostics GmbH (HSA 600:41/01-016/18/13_70)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-18-13_70 FSN106 KB
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29 Aug 2018
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Alinity HQ Analyzer, Abbott (HSA 600:41/01-005/18/11_57)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: 6914 8290 / FSN_enquiry@abbott.com
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HSA 6004101-005-18-11_57 FSN291 KB
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29 Aug 2018
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VITROS XT 7600 Integrated System, Ortho Clinical Diagnostics (HSA 600:41/01-303/18/11_75)
Local Contact: ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD
Contact no./Email: 6486 1151
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HSA 6004101-303-18-11_75 FSN187 KB
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28 Aug 2018
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HemosIL ReadiPLasTin, Instrumentation Laboratory Company (HSA 600:41/01-033/18/04_73)
Local Contact: Biomed Diagnostics Pte Ltd
Contact no./Email: 6298 4347 / biomed.regulatory@biomed-global.com
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HSA 6004101-033-18-04_73 FSN_Redacted499 KB
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28 Aug 2018
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CoaguChek PT, XS PT, XS PT PST Test, Roche Diagnostics GmbH (HSA 6004101-016-18-12_69)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-18-12_69 FSN583 KB
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27 Aug 2018
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VITEK 2 Antimicrobial Automated Susceptibility Test, bioMerieux (HSA 600:41/01-146/18/06_34)
Local Contact: Biomerieux Singapore Pte Ltd
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HSA 6004101-146-18-06_34 FSN_Redacted435 KB
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27 Aug 2018
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D-100 HEMOGLOBIN TESTING SYSTEM, Bio Rad Laboratories, Inc (HSA 600:41/01-027/18/12_67)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
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HSA 6004101-027-18-12_67 FSN81 KB
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25 Aug 2018
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Medtronic HeartWare™ HVAD™ Controller, HeartWare Inc. (HSA 600:41/01-263/18/03_77)
Local Contact: Emergo Consulting Pte Ltd
Contact no./Email: 6854 7976 / SEAsiaVigilance@ul.com
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HSA 6004101-263-18-03_77 FSN_Redacted539 KB
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24 Aug 2018
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Zenith Alpha Thoracic Endovascular Graft, William Cook Europe Aps (HSA 600:41/01-013-18-07_76)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com
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HSA 6004101-013-18-07_76 FSN_Redacted196 KB
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24 Aug 2018
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Endologix AFX Endovascular AAA System, Endologix, Inc (HSA 600:41/01-057/18/02_18)
Local Contact: Somnotec (S) Pte Ltd
Contact no./Email: 6844 0002 / info@somnotec.net
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HSA 6004101-057-18-02_18 FSN_Redacted899 KB
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23 Aug 2018
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Invivo Xper Flex Cardio Physiomonitoring System, Invivo, a division of Philips Medical Systems (HSA 600:41/01-026/18/23_74)
Local Contact: Philips Electonics (Singapore) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-18-23_74 FSN_Redacted84 KB
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23 Aug 2018
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Therakos CELLEX Photopheresis System, Therakos Inc. (HSA 600:41/01-070/18/19_74)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regional.pms@transmedicgroup.com
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HSA 6004101-070-18-19_74 FSN_Redacted483 KB
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21Aug 2018
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MyLab SevenAlpha, MyLab Seven, MyLab Six Crystaline, MyLab Six, MyLab Gamma, MyLabClass C, MyLab Eight, MyLab60/65/70/75, MyLab70 X Vision and MyLab70 XV-L, Esaote SpA (HSA 600:41/01-288/18/02_38)
Local Contact: Medical Plus Pte Ltd
Contact no./Email: 6271 6558
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HSA 6004101-288-18-02_38 FSN_Redacted96 KB
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21Aug 2018
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VITROS 5600 Integrated System, Ortho-Clinical Diagnostics, Inc. (HSA 600:41/01-303/18/10_70)
Local Contact: ORTHO-Clinical Diagnostics Singapore Pte. Ltd
Contact no./Email: 6486 1151
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HSA 6004101-303-18-10_70 FSN490 KB
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21Aug 2018
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VIROTRIOL HIV-1 Ag, Bio-Rad Laboratories (HSA 600:41/01-027/18/11_49)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
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HSA 6004101-027-18-11_49 FSN115 KB
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20 Aug 2018
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DxTerity™ Diagnostic Catheter, Medtronic Inc (HSA 600:41/01-009/18/14_38)
Local Contact: Medtronic International Ltd.
Contact no./Email: 6436 5077
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HSA 6004101-009-18-14_38 FSN_Redacted677 KB
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16 Aug 2018
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YUKON Polyaxial Screws, K2M, Inc (HSA 600:41/01-070/18/18_66)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regional.pms@transmedicgroup.com
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HSA 6004101-070-18-18_66 FSN Redacted311 KB
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16 Aug 2018
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Da Vinci S/SI and Da Vinci Monopolar Curved Scissor (MCS), Intuitive Surgical, Inc (HSA 600:41/01-070/18/17_66)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regional.pms@transmedicgroup.com
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HSA 6004101-070-18-17_66 FSN268 KB
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16 Aug 2018
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Thio Med w/ Dex, Remel Inc (Thermo Fisher Scientific ) (HSA 600:41/01-178/18/06_31)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6362 9390
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HSA 6004101-178-18-06_31 FSN_Redacted236 KB
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15 Aug 2018
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Aptio Automation, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/18/21_75)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-21_75 FSN112 KB
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15 Aug 2018
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UniCel DxH 800 Coulter Cellular Analysis System, Beckman Coulter Inc (HSA 600:41/01-052/18/03_23)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 6340 7126
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HSA 6004101-052-18-03_23 FSN_Redacted138 KB
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14 Aug 2018
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Doro Lucent Headrest System, Pro Med Instruments GmbH (HSA 600:41/01-053/18/01_64)
Local Contact: Humedical (S) Pte Ltd
Contact no./Email: 6872 1738 / sales@humedical.com
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HSA 6004101-053-18-01_64 FSN_Redacted635 KB
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14 Aug 2018
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Covidien BIS Complete Monitoring System and Covidien BIS View Monitoring System, Covidien LLC (HSA 600:41/01-046/18/10_71)
Local Contact: Covidien Private Limited
Contact no./Email: 6439 6974
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HSA 6004101-046-18-10_71 FSN_Redacted646 KB
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13 Aug 2018
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9735345 S7 Install Media Tools Database Version 1.288, 9736041 StealthStation Tools Database Version 1.288, Medtronic Navigation Inc (HSA 600:41/01-009/18/12_46)
Local Contact: Medtronic International Limited
Contact no./Email: 6439 5000
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HSA 6004101-009-18-12_46 FSN_Redacted107 KB
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13 Aug 2018
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OptiView DAB IHC Detection Kit, ultraView Universal Alkaline, Phosphatase Red Detection Kit, ISH Protease 3, VEMTAMA ISH iView Blue Detection Kit, Ventana Medical Systems, Inc (HSA 600:41/01-016/18/11_73)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-18-11_73 FSN417 KB
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13 Aug 2018
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Medtronic MiniMed Remote Controller, Medtronic MiniMed (HSA 600:41/01-009/18/13_48)
Local Contact: Medtronic International Ltd.
Contact no./Email: 6439 5000
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HSA 6004101-009-18-13_48 FSN_Redacted205 KB
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13 Aug 2018
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Hematek Wright Giemsa Stain Pak and Hematek Modified Wright Stain Pak, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/18/20_49)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-20_49 FSN19 KB
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10 Aug 2018
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Power supply units for the sleep therapy devices SOMNObalance, SOMNOsoft 2, prisma SOFT and prism SMART, Löwenstein Medical Technology GmbH + Co. KG (HSA 600:41/01-264/18/01_56)
Local Contact: Easmed Asia Pte Ltd
Contact no./Email: 6471 3133
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HSA 6004101-264-18-01_56 FSN_Redacted204 KB
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08 Aug 2018
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Capnostream 20 and Capnostream 20p Bedside Patient Monitors, Covidien LLC (HSA 600:41/01‐046/18/09_54)
Local Contact: Covidien Private Limited
Contact no./Email: 6439 6974
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HSA 6004104-046-18-09_54 FSN_Redacted1338 KB
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08 Aug 2018
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sterEOS Image Review Workstation, EOS Imaging (HSA 600:41/01-238/18/01_52)
Local Contact: QST Technologies Pte Ltd
Contact no./Email: 6270 6260 / service.sg@qsttech.com
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HSA 6004101-238-18-01_52 FSN987 KB
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07 Aug 2018
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Genesis II Non Porous C/R Femoral Size 6 Right, Smith & Nephew, Inc. (HSA 600:41/01-073/18/17_71)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-18-17_71 FSN62 KB
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07 Aug 2018
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Carestation 620/650/650c A1, Carestation 620/650/650c A2, Carestation 30 and 9100c NXT Anesthesia Systems, Datex-Ohmeda (HSA 600:41/01-010/18/17_50)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-17_50 FSN_Redacted309 KB
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07 Aug 2018
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Ysio and Ysio Max with Tube stand 3D V, Siemens Healthcare GmbH (HSA 600:41/01-022/18/19_63)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-19_63 FSN Redacted1330 KB
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06 Aug 2018
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Elekta Mosaiq, IMPAC Medical Systems, Inc (HSA 600:41/01-101/18/04_35)
Local Contact: Elekta Pte Ltd
Contact no./Email: 6221 2322 / Elekta_Global_PMS@elekta.com
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HSA 6004101-101-18-04_35 FSN_Redacted1379 KB
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06 Aug 2018
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Stellaris Elite™ Single Port Vitrectomy Cutters in Gauge Sizes 20, 23, and 25, Bausch & Lomb Incorporated (HSA 600:41/01-030/18/01_44)
Local Contact: Bausch & Lomb (Singapore) Pte Ltd
Contact no./Email: 6834 9112
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HSA 6004101-030-18-01_44 FSN Redacted456 KB
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06 Aug 2018
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Juggerknot Long Flex Drill Bit with Sleeve Nitinol Stainless Steel, Biomet Orthopaedics (HSA 600:41/01-008/18/13_18)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-18-13_18 FSN130 KB
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06 Aug 2018
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Philips Allura Xper FD10 X-Ray Imaging System, Philips Allura Xper FD10/10 X-Ray Imaging System, Philips Allura Xper FD20 X-Ray Imaging System, Philips Medical Systems Nederland BV (HSA 600:41/01-026/18/22_51)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-18-22_51 FSN_Redacted254 KB
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01 Aug 2018
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CONMED Hall® Small Lithium Battery L3000SM, ConMed Corporation (HSA 600:41/01-302/18/01_46)
Local Contact: ConMed Singapore Pte Ltd
Contact no./Email: 6255 4768
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HSA 6004101-302-18-01_46 FSN_Redacted109 KB
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06 Dec 2017
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MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLATE-RM/LL-SZ 7, MAKO Surgical Corp (HSA 600:41/01-070/17/20_64)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-17-20_64 FSN_Redacted104 KB
This FSN is an update to the original FSN published in Dec 2017.
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