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Date of Notification
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Title
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FSN
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28 Sep 2018
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Medtronic FlexCath Advance Steerable Sheath, Medtronic CryoCath LP (HSA 600:41/01-009/18/16_46)
Local Contact: Medtronic lnternational Limited
Contact No./Email: 6436 5077
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HSA 6004101-009-18-16_46 FSN_Redacted137 KB
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28 Sep 2018
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HydroSet Injectable HA Bone Substitute, Stryker Leibinger GmbH & Co. KG (HSA 600:41/01-014/18/07_68)
Local Contact: Stryker Singapore Pte Ltd
Contact No./Email: asean.pms@stryker.com
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HSA 6004101-014-18-07_68 FSN_Redacted109 KB
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28 Sep 2018
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25GA Vitrectomy Cutter, Johnson & Johnson Surgical Vision Inc. (HSA 600:41/01-018/18/01_18)
Local Contact: AMO Singapore Pte Ltd
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HSA 6004101-018-18-01_18 FSN_Redacted113 KB
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27 Sep 2018
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buddy™ Disposable Set, Belmont Instrument Corporation (HSA 600:41/01-070/18/20_63)
Local Contact: Transmedic Pte Ltd
Contact No./Email: 6477 6101 / regional.pms@transmedicgroup.com
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HSA 6004101-070-18-20_63 FSN_Redacted248 KB
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27 Sep 2018
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ATELLICA® IM 1300 ANALYZER, ATELLICA® IM 1600 ANALYZER, ATELLICA® CH 930 ANALYZER, ATELLICA® SAMPLE HANDLER PRIME, Siemens Healthcare Diagnostic Inc. (HSA 600:41/01-022/18/24_57)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui.handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-24_57 FSN107 KB
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27 Sep 2018
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INTRAFIX SAFESET LL, B.Braun Melsungen AG (HSA 600:41/01-012/18/07_50)
Local Contact: B.Braun Singapore Pte Ltd
Contact No./Email: 6213 0933 / press.sg@bbraun.com
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HSA 6004101-012-18-07_50 FSN_Redacted1229 KB
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26 Sep 2018
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CrystaIClear Plus; RUSCH CARE CrystaIClear (PVC) Tracheostomy Cannula (no Cuff) ‐ Set; RUSCH CrystaIClear (PVC) Tracheostomy Cannula (Cuffed); RUSCH CrystalClear (PVC) Tracheostomy Cannula (no Cuff), Teleflex Medical Europe (HSA 600:41/01-139/18/04_51)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact No./Email: 6439 3046
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HSA 6004101-139-18-04_51 FSN_Redacted506 KB
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26 Sep 2018
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Xper Flex Cardio Patient Monitoring System, Invivo (a division of Philips Medical Systems), (HSA 600:41/01-026/18/25_63)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477
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HSA 6004101-026-18-25_63 FSN_Redacted138 KB
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26 Sep 2018
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LOGIQ E10 Ultrasound Systems combined with TEE probes, GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC (HSA 600:41/01-010/18/22_50)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-22_50 FSN_Redacted283 KB
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26 Sep 2018
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Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP), Datascope Corp (HSA 600:41/01-017/18/05_35)
Local Contact: IDS Medical Systems (S) Pte Ltd
Contact No./Email: 6690 7330
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HSA 6004101-017-18-05_35 FSN_Redacted415 KB
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25 Sep 2018
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Roche Diagnostics Elecsys® FT4 III, Roche Diagnostics GmbH (HSA 600:41/01-016/18/15_73)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com
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HSA 6004101-016-18-15_73 FSN355 KB
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23 Sep 2018
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StageOne Hip Cement Spacer Mold, Biomet Orthopaedics (HSA 600:41/01-008/18/14_48)
Local Contact: Zimmer Pte Ltd
Contact No./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-18-14_48 FSN_Redacted97 KB
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22 Sep 2018
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ConvaTec Feeding Tubes; ConvaTec Ryles tubes; ConvaTec Mülly Suction Catheter Set; Convatec / Nelaton and Female PVC intermittent Catheters, Convatec Limited (HSA 600:41/01-044/18/01_18)
Local Contact: Optimal Medical Products Pte Ltd
Contact No./Email: 6253 5247 / sales@optimalmedical.com.sg
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HSA 6004101-044-18-01_18 FSN_Redacted875 KB
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20 Sep 2018
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B20/B20i/B40/B40i (Bx0), and B105/B125 (B1x5) Patient Monitors, GE Medical Systems Information Technologies, Inc. (HSA 600:41/01-010/18/21_77)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-21_77 FSN_Redacted136 KB
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20 Sep 2018
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ABX Difftrol, Horiba ABX SAS (HSA 600:41/01-137/18/02_69)
Local Contact: All Eights Pte Ltd
Contact No./Email: 6288 6388 / alleight@alleight.com
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HSA 6004101-137-18-02_69 FSN_Redacted141 KB
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19 Sep 2018
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Acid Concentrate for Bicarbonate Haemodialysis, Fresenius Medical Care Production Sdn Bhd (HSA 600:41/01-062/18/02_74)
Local Contact: Fresenius Medical Care Singapore Pte Ltd
Contact No./Email: 6837 3113
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HSA 6004101-062-18-02_74 FSN _Redacted1864 KB
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19 Sep 2018
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ALINITY I PROCESSING MODULE, Abbott GmbH & Co. KG (HSA 600:41/01-005/18/18_67)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com
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HSA 6004101-005-18-18_67 FSN_Redacted198 KB
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18 Sep 2018
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Ghiatas® Beaded Breast Localization Wire, Bard Peripheral Vascular, Inc (HSA 600:41/01-050/18/05_71)
Local Contact: Bard Singapore Pte Ltd
Contact No./Email: 6580 5988 / complaints.singapore@crbard.com
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HSA 6004101-050-18-05_71 FSN_Redacted1825 KB
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18 Sep 2018
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Dash 3000/4000/5000, Solar 8000M/i, and Solar 9500 Patient Monitors, GE Medical Systems Information Technologies, Inc (HSA 600:41/01-010/18/20_38)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-20_38 FSN_Redacted355 KB
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17 Sep 2018
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System DRX Ascend/Q-Rad System, Carestream Health, Inc. (HSA 600:41/01-187/18/01_64)
Local Contact: Carestream Singapore Pte Ltd
Contact No./Email: 6501 5007
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HSA 6004101-187-18-01_64 FSN_Redacted220 KB
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17 Sep 2018
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COOPERSURGICAL SINGLE-USE CPO-6 COLPO-PNEUMO OCCLUDER™, CooperSurgical Inc (HSA 600:41/01-017/18/04_62)
Local Contact: IDS Medical Systems (S) Pte Ltd
Contact No./Email: 6690 7330
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HSA 6004101-017-18-04_62 FSN_Redacted2554 KB
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17 Sep 2018
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CooperSurgical 5mm Elastic Stays, Blunt End, CooperSurgical Inc. (HSA 600:41/01-145/18/01_48)
Local Contact: Medquest Marketing Pte Ltd
Contact No./Email: 6805 1250
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HSA 6004101-145-18-01_48 FSN_Redacted2722 KB
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17 Sep 2018
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Terumo® Advanced Perfusion System 1, Terumo Cardiovascular Systems Corporation (HSA 600:41/01-028/18/06_51)
Local Contact: Terumo Singapore Pte Ltd
Contact No./Email: 6291 3603
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HSA 6004101-028-18-06_51 FSN156 KB
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14 Sep 2018
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Gambro AK 98 Dialysis Machine, Gambro Lundia AB (HSA 600:41/01-001/18/04_46)
Local Contact: Baxter Healthcare (Asia) Pte Ltd
Contact No./Email: 6826 2616
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HSA 6004101-001-18-04_46 FSN_Redacted322 KB
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14 Sep 2018
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Aptio Automation System, Inpeco SA (HSA 600:41/01-022/18/23_61)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui.handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-23_61 FSN_Redacted133 KB
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13 Sep 2018
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CARESCAPE B450 and B850 monitors, GE Healthcare Finland Oy (HSA 600:41/01-010/18/19_56)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-19_56 FSN_Redacted670 KB
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13 Sep 2018
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B. Braun SpaceCover Comfort & B Braun SpaceCover Standard, B Braun Melsungen AG (HSA 600:41/01-012/18/06_64)
Local Contact: B.Braun Singapore Pte Ltd
Contact No./Email: 6213 0933 / press.sg@bbraun.com
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HSA 6004101-012-18-06_64 FSN72 KB
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11 Sep 2018
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ARCHITECT Alere NT-proBNP for ARCHITECT Controls 2R10-10, Axis-Shield Diagnostics Ltd (HSA 600:41/01-005/18/17_70)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact No./Email: 6941 8000/ FSN@enquiry@abbott.com
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HSA 6004101-005-18-17_70 FSN_Redacted108 KB
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10 Sep 2018
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Centricity Universal Viewer, GE Healthcare (HSA 600:41/01-010/18/18_35)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-18_35 FSN_Redacted284 KB
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10 Sep 2018
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ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 pacemakers and VISIONIST and VALITUDE CRT-Ps, Boston Scientific Corporation (HSA 600:41/01-007/18/05_62)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact No./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-18-05_62 FSN_Redacted225 KB
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10 Sep 2018
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ADVIA Chemistry Creatinine Kinase (CK_L) Assay, Siemens Healthcare Diagnostic Inc. (HSA 600:41/01-022/18/22_59)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-22_59 FSN123 KB
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7 Sep 2018
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CentriMag Motor, Thoratec Switzerland GmbH (HSA 600:41/01-005/18/16_51)
Local Contact: Abbott Medical (Singapore) Pte Ltd Contact No./Email: 6643 2800 / FSN_enquiry@abbott.com
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HSA 6004101-005-18-16_51 FSN_Redacted574 KB
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7 Sep 2018
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Accu-Chek® Inform II system, cobas h 232 POC system, CoaguChek® Pro II system, CoaguChek® XS Plus / XS Pro system, Roche Diagnostics GmbH (HSA 600:41/01-016/18/14_34)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com
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HSA 6004101-016-18-14_34 FSN_Redacted609 KB
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7 Sep 2018
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FilmArray Blood Culture Identification (BCID) Panel, BioFire Diagnostic, LLC (HSA 600:41/01-146/18/07_31)
Local Contact: BIOMERIEUX SINGAPORE PTE. LTD.
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HSA 6004101-146-18-07_31 FSN_Redacted477 KB
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7 Sep 2018
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O-Arm 1000 Imaging System, Medtronic Navigation Inc (HSA 600:41/01-009/18/15_52)
Local Contact: Medtronic International Ltd.
Contact No./Email: 6439 5000
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HSA 6004101-009-18-15_52 FSN_Redacted909 KB
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7 Sep 2018
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Abbott Alinity c Creatine Kinase, Abbott Alinity c Creatine Kinase (HSA 600:41/01-005/18/15_57)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN@enquiry@abbott.com
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HSA 6004101-005-18-15_57 FSN_Redacted291 KB
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7 Sep 2018
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GibcoTM MEM Non-Essential Amino Solution (100X); GibcoTM GlutaMAXTM Supplement; GibcoTM Sodium Pyruvate (100mM); GibcoTM DPBS, calcium, magnesium, Life Technologies Corporation (HSA 600:41/01-220/18/02_67)
Local Contact: Life Technologies Holdings Pte Ltd
Contact No./Email:6362 9574
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HSA 6004101-220-18-02_67 FSN_Redacted336 KB
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7 Sep 2018
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MyLab Six and MyLab Gamma, Esaote SpA (HSA 600:41/01-263/18/04_52)
Local Contact: Emergo Consulting Pte Ltd
Contact No./Email: 6854 7976 / SEAsiaVigilance@ul.com
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HSA 6004101-263-18-04_52 FSN_Redacted97 KB
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6 Sep 2018
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Alinity ci‐series System Control Module (SCM), Abbott GmbH & Co. KG (HSA 600:41/01-005/18/14_23)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8290 / FSN_enquiry@abbott.com
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HSA 6004101-005-18-14_23 FSN392 KB
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6 Sep 2018
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ABL90 FLEX (393-090) analyzers, Radiometer Medical Aps (HSA 600:41/01-219/18/01_75)
Local Contact: Radiometer S.E.A Pte Ltd
Contact No./Email: 6389 6027
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HSA 6004101-219-18-01_75 FSN38 KB
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5 Sep 2018
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VirtuoSaph® Plus Endoscopic Vessel Harvesting System, Terumo Cardiovascular Systems Corporation (HSA 600:41/01-028/18/05_77)
Local Contact: Terumo Singapore Pte Ltd
Contact No./Email: 6291 3603
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HSA 6004101-028-18-05_77 FSN292 KB
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5 Sep 2018
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Terumo® Advanced Perfusion System 1, Terumo Cardiovascular Systems Corp (HSA 600:41/01-028/18/04_50)
Local Contact: Terumo Singapore Pte Ltd
Contact No./Email: 6291 2603
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HSA 6004101-028-18-04_50 FSN322 KB
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5 Sep 2018
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MEDUMAT Transport with and without CO2 measurement (WM 28300 and WM 28400) incl. Akku-Pack or Akku-Pack PLUS rechargeable battery packs; Akku-Pack rechargeable battery pack (WM 28384); Akku-Pack PLUS rechargeable battery pack (WM 28385), WEINMANN Emergency Medical Technology GmbH + Co. KG (HSA 600:41/01-056/18/04_44)
Local Contact: Gold Lite Pte Ltd
Contact No./Email: 6273 0487
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HSA 6004101-056-18-04_44 FSN_Redacted161 KB
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4 Sep 2018
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VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Ortho-Clinical Diagnostics (HSA 600:41/01-303/18/12_34)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact No./Email: 6486 1151
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HSA 6004101-303-18-12_34 FSN_Redacted369 KB
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4 Sep 2018
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CyPass® Micro-Stent, Alcon Laboratories, Inc. (HSA 600:41/01-135/18/01_35)
Local Contact: Alcon Pte Ltd
Contact No./Email: 6722 1255
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HSA 6004101-135-18-01_35 FSN_Redacted632 KB
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28 Aug 2018
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CoaguChek PT, XS PT, XS PT PST Test, Roche Diagnostics GmbH (HSA 600:41/01-016/18/12_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 FSN v2663 KB
This updated FSN replaces the original FSN published in Aug 2018.
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26 Jun 2018
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CARESCAPE B650 Monitor, GE Healthcare Finland Oy (HSA 600:41/01-010/18/14_56)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-14_56 FSN_v2_Redacted669 KB
This FSN is an update to the original FSN published in June 2018.
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21 May 2018
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Cobas m 511 integrated hematology analyser, Roche Diagnostics GmbH (HSA 600:41/01-016/18/09_59)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com
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HSA 6004101-016-18-09_59 FSN_version 2796 KB
This FSN is an update to the original FSN published in May 2018.
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10 Nov 2017
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Covidien Puritan Bennett 980 Series Ventilator, Covidien IIc (HSA 600:41/01-046/17/09_37)
Local Contact: Covidien Pte Ltd
Contact No./Email: 6439 6974
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HSA 6004101-046-17-09_37 FSN Part 2_Redacted148 KB
This FSN is an update to the original FSN published in Nov 2017.
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30 Jun 2016
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Philips M1783A/M5526A Sync Cables & 989803195641 ECG Out Cables, Philips Medical Systems (HSA 600:41/01-026/16/26_41)
Local Contact: Philips Electronics (S) Pte Ltd
Contact No./Email: 1800 744 5477
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HSA 6004101-026-16-26_41 FSN_Update_Redacted83 KB
This FSN is an update.
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