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Date of Notification
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Title
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FSN
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27 Feb 2018
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HeartStart FRx, HeartStart Onsite, HeartStart Home AEDs, Philips Medical Systems (HSA 600:41/01-026/18/10_62)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 774 5477
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HSA 6004101-026-18-10_62 FSN204 KB
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27 Feb 2018
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Versatex™ Monofilament Mesh 50 x 50 cm, Sofradim Production (HSA 600:41/01-046/18/02_40)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6933
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HSA 6004101-046-18-02_40 FSN_Redacted674 KB
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27 Feb 2018
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REMEL™ R30166601 - NEISSERIA MENINGITIDIS POLY A-D 2ML/VL; REMEL™ R30167001 - NEISSERIA MENINGITIDIS GROUP D 2ML/VL, Remel Europe Ltd (HSA 600:41/01-178/18/01_57)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6499 9999 / cs.mbd.sg@thermofisher.com
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HSA 6004101-178-18-01_57_FSN_Redacted226 KB
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26 Feb 2018
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VITEK® 2 Compact 15; VITEK® 2 Compact 30 system; bioMerieux, Inc. (HSA 600:41/01-146/18/03_69)
Local Contact: Biomerieux Singapore Pte Ltd
Contact no./Email: 6801 6700
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HSA 6004101-146-18_03_69 FSN315 KB
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26 Feb 2018
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Quick connect scale used with Maxi Sky 2 ceiling lifts, ArjoHuntleigh AB (HSA 600:41/01-065/18/01_56)
Local Contact: Arjo South East Asia Pte. Ltd.
Contact no./Email: Tel: 6202 7366 / singapore@arjo.com
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HSA 6004101-065-18-01_56 FSN_Redacted256 KB
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23 Feb 2018
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MeniCare SoR 70ML, Menicon Co., Ltd (HSA 600:41/01-319/18/02_46)
Local Contact: Menicon Singapore Sales Pte Ltd.
Contact no./Email: 6411 4778
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HSA 6004101-319-18-02_46 FSN_Redacted7039 KB
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21 Feb 2018
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COBAS B 221 <2> SYSTEM, COBAS B 221 <4> SYSTEM, COBAS B 221 <6> SYSTEM, AUTOQC MODULE COMPLETE COBAS B 221, Roche Diagnostics GmbH (HSA 600:41/01-016/18/02_67)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: 6272 7500 / sg.regulatory@roche.com
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HSA 6004101-016-18-02_67 FSN607 KB
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21 Feb 2018
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Flow QC Tubing, Transonic Systems Inc. (HSA 600:41/01-070/18/04_43)
Local Contact: Transmedic Pte Ltd
Contact no./Email:6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-18-04_43 FSN_Redacted5966 KB
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20 Feb 2018
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Oncor Impression Plus, Siemens Healthcare GmbH (HSA 600:41/01-022/18/06_46)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-06_46 FSN33 KB
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20 Feb 2018
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URF-P6/P6R, URF-V2/V2R URETERO-RENO ENDOSCOPES, Olympus Medical Systems Corp. (HSA 600:41/01-004/18/01_52)
Local Contact: Olympus Singapore Pte Ltd
Contact no./Email: 6833 4214 / mes-ra.osp@olympus-ap.com
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HSA 6004101-004-18-01_52 FSN_Redacted1292 KB
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14 Feb 2018
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Infinity Acute Care System (IACS), Infinity M540 patient monitor, Draeger Medical Systems, Inc. (HSA 600:41/01-063/18/01_63)
Local Contact: Draeger Singapore Pte Ltd
Contact no./Email: 6872 9288 / draeger.sg@draeger.com
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HSA 6004101-063-18-01_63 FSN_Redacted145 KB
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12 Feb 2018
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Alinity ci-series System Control Module (SCM), Abbott GmbH & Co. KG (HSA 600:41/01-005/18/01_31)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com
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HSA 6004101-005-18-01_31 FSN136 KB
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12 Feb 2018
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TEE probes: 6VT-D, 6Tc, 6Tc-RS, 9T, 9T-RS, 6T, 6T-RS, GE Vingmed Ultrasound AS (HSA 600:41/01-010/18/03_51)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-03_51 FSN_Redacted358 KB
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12 Feb 2018
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Barrx™ 360 Express RFA Balloon Catheter, Covidien llc (HSA 600:41/01-046/18/01_44)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6933
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HSA 6004101-046-18-01_44 FSN_Redacted131 KB
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12 Feb 2018
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VeriQ Systems, VeriQ C Systems, MiraQ Systems, Medistim ASA (HSA 600:41/01-218/18/01_40)
Local Contact: Perfusion Services and Supplies Pte Ltd
Contact no./Email: 6398 0630
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HSA 6004101-218-18-01_40 FSN_Redacted541 KB
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12 Feb 2018
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Capio Suture Capturing Devices (SLIM, Standard, Open Access, RP), Uphold Vaginal Support System, Uphold LITE with Capio SLIM Vaginal Support System, Pinnacle Anterior Pelvic Floor Repair Kit, Pinnacle Posterior Pelvic Floor Repair Kit, Pinnacle LITE posterior with CAPIO SLIM Pelvic Floor Repair Kit, Boston Scientific Corporation (HSA 600:41/01-007/18/01_49)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 64188 888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-18-01_49 FSN_Redacted1909 KB
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12 Feb 2018
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VITROS Chemistry Products %A1c Performance Verifiers I&II, Ortho Clinical Diagnostics Inc (HSA 600:41/01-303/18/03_61)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 6486 1151
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HSA 6004101-303-18-03_61 FSN_Redacted1567 KB
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09 Feb 2018
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Allura Xper with FlexVision large screen monitor, Philips Medical Systems Nederland BV (HSA 600:41/01-026/18/09_37)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-18-09_37 FSN_Redacted105 KB
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09 Feb 2018
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Invivo DynaCAD Software, Invivo Corporation (HSA 600:41/01-026/18/08_45)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 774 5477
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HSA 6004101-026-18-08_45 FSN_Redacted295 KB
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09 Feb 2018
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EXACTRAC VERSION 6.0 - 6.5, Brainlab AG (HSA 600:41/01-047/18/01_25)
Local Contact: Brainlab Limited
Contact no./Email: 6734 1701 / sg.regulatory@brainlab.com
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HSA 6004101-047-18-01_25 FSN_Redacted69 KB
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09 Feb 2018
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3M™ Surgical Clipper Professional 9681, 3M Health Care (HSA 600:41/01-031/18/01_35)
Local Contact: 3M Technologies (S) Pte Ltd
Contact no./Email: 6450 8846
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HSA 6004101-031-18-01_35 FSN_Redacted220 KB
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07 Feb 2018
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Somatom Emotion, Sensation, Spirit, Scope, Perspective, Siemens Healthcare GmbH (HSA 600:41/01-022/18/05_71)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-05_71 FSN-01a_Redacted8645 KB
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07 Feb 2018
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Arctic Sun 5000 Temperature Management System, Bard Limited (HSA 600:41/01-050/18/01_66)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: 6580 5988 / Complaints.Singapore@crbard.com
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HSA 6004101-050-18-01_66 FSN_Redacted3257 KB
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07 Feb 2018
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BIO-CAL Temperature Controller, Medtronic Inc (HSA 600:41/01-009/18/02_18)
Local Contact: Medtronic International Limited
Contact no./Email: 6346 5077
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HSA 6004101-009-18-02_18 FSN_Redacted1846 KB
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06 Feb 2018
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Legion HK Distal Femoral Wedge SZ5 5mm, Smith & Nephew Inc. (HSA 600:41/01-073/18/02_56)
Local Contact:Smith & Nephew Pte. Ltd.
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-18-02_56 FSN173 KB
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06 Feb 2018
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VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody, Roche Diagnostics GmbH (HSA 600:41/01-016/18/01_58)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-18-01_58 FSN418 KB
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06 Feb 2018
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ORBIT INCISOR PLUS EP-1 (6/BX), Smith & Nephew Inc (HSA 600:41/01-073/18/03_49)
Local Contact: Smith & Nephew Pte. Ltd.
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-18-03_49 FSN118 KB
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06 Feb 2018
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Somatom Emotion, Spirit/Power, Scope/Power, Perspective, Siemens Shanghai Medical Equipment Ltd (HSA 600:41/01-022/18/04_68)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-04_68 FSN_Redacted4680 KB
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06 Feb 2018
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Dornier Gemini, Dornier MedTech GmbH (HSA 600:41/01-161/18/01_64)
Local Contact: Dornier MedTech Asia Pte Ltd
Contact no./Email: 6572 6056 / asiaregulatory@dornier.com
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HSA 6004101-161-18-01_64 FSN_Redacted965 KB
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05 Feb 2018
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Triathlon TS Augments, Howmedica Ostenics Corp (HSA 600:41/01-014/18/03_45)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com
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HSA 6004101-014-18-03_45 FSN_Redacted103 KB
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02 Feb 2018
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Proteus 235 - Proton Therapy System, Ion Beam Applications S.A. (HSA 600:41/01-070/18/03_71)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6737 1945 / regulatory@transmedicgroup.com
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HSA 6004101-070-18-03_71 FSN315 KB
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02 Feb 2018
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Centricity Universal Viewer with PACS-IW foundation 6.0 and Centricity PACS-IW with Universal Viewer version 5.0, GE Healthcare (HSA 600:41/01-010/18/02_66)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-02_66 FSN_Redacted291 KB
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