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Date of Notification
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Title
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FSN
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30 Nov 2017
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INTRO-FLEX SHEATH INTRODUCERS, Edwards Lifesciences (HSA 600:41/01-060/17/01_54)
Local Contact: Edwards Lifesciences (Asia) Pte Ltd
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HSA 6004101-060-17-01_54 FSN111 KB
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29 Nov 2017
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CADD Medication Cassette Reservoir, Smiths Medical ASD, Inc (HSA 600:41/01-017/17/05_51)
Local Contact: IDS Medical Systems (S) Pte Ltd
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HSA 6004101-017-17-05_51 FSN_Redacted1457 KB
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27 Nov 2017
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DiaSys Antistreptolysin O FS, DiaSys Diagnostic Systems GmbH (HSA 600:41/01-032/17/05_60)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 6221 3629 / RA@sysmex-ap.com
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HSA 6004101-032-17-05_60 FSN408 KB
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24 Nov 2017
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Abbott Alinity hq Analyzer, Abbott GmbH & Co. KG (HSA 600:41/01-005/17/24_60)
Local Contact: ABBOTT Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8290 / FSN_enquiry@abbott.com
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HSA 6004101-005-17-24_60 FSN304 KB
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24 Nov 2017
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Puritant Bennett 980 Ventilators Rechargeable Li-ion Batteries, Covidien llc (HSA 600:41/01-046/17/10_40)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6974
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HSA 6004101-046-17-10_40 FSN_Redacted975 KB
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24 Nov 2017
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Accuray TomoTherapy Hi Art System, Accuray Incorporated (HSA 600:41/01-070/17/19_44)
Local Contact:Transmedic Pte Ltd
Contact no./Email: 64776101 / regulatory@transmedicgroup.com
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HSA 6004101-070-17-19_44 FSN_Redacted3493 KB
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23 Nov 2017
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Thermo Scientific™ Remel™ Shigella sonnei (Phases 1&2) Agglutinating Serum, Thermo Fisher Scientific (HSA 600:41/01-178/17/07_59)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6499 9999 / cs.mbd.sg@thermofisher.com
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HSA 6004101-178-17-07_59_FSN_Redacted155 KB
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23 Nov 2017
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Proteus 235 - Proton Therapy System, Ion Beam Applications S.A. (HSA 600:41/01-070/17/18_54)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6737 1945 / regulatory@transmedicgroup.com
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HSA 6004101-070-17-18_54 FSN_edited224 KB
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22 Nov 2017
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Cook Reuter Tip Deflecting Wire Guide DTDW, Cook Incorporated (HSA 600:41/01-013/17/06_68)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400; SNG-RegulatoryAffairs@cookmedical.com
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HSA 6004101-013-17-06_68_FSN_Redacted937 KB
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22 Nov 2017
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COOK Fallopian Tube Catheterization Sets, Cook Incorporated (HSA 600:41/01-013/17/07_71)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com
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HSA 6004101-013-17-07_71 FSN_Redacted102 KB
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21 Nov 2017
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Abbott Laboratories CELL-DYN Ruby System, Abbott Laboratories (HSA 600:41/01-005/17/23_58)
Local Contact: Abbott Laboratories Pte Ltd
Contact no./Email: 6914 8290 / FSN_enquiry@abbott.com
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HSA 6004101-005-17-23_58 FSN343 KB
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21 Nov 2017
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Stryker Instruments - multiple disposable products, Stryker Instruments (HSA 600:41/01-014/17/07_18)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: asean.pms@stryker.com
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HSA 6004101-014-17-07_18 FSN137 KB
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20 Nov 2017
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JETX BAR FREEDOM CLAMP 10.5MM TO 5MM, Smith & Nephew, Inc (HSA 600:41/01-073/17/17_46)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-17-17_46 FSN58 KB
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17 Nov 2017
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Medtronic Synchromed II Programmable Drug Infusion System, Medtronic Inc. (HSA 600:41/01-009/17/22_63)
Local Contact: Medtronic International Ltd
Contact no./Email: 6436 5000
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HSA 6004101-009-17-22_63 FSN_Redacted194 KB
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15 Nov 2017
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Polyganics Nasopore Dressing (Polyganics 8cm Nasal Dressing), Polyganics BV (HSA 600:41/01-264/17/01_50)
Local Contact:Easmed Asia Pte Ltd
Contact no./Email: 6471 3133
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HSA 6004101-264-17-01_50 FSN_Redacted1352 KB
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14 Nov 2017
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DEFIGARD Touch 7, Schiller Medical S.A.S (HSA 600:41/01-056/17/06_36)
Local Contact:Gold Lite Pte Ltd
Contact no./Email: 6273 0487
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HSA 6004101-056-17-06_36 FSN_Redacted116 KB
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13 Nov 2017
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Anaconda Longer Leg Iliac Stent Graft System, Vascutek Ltd (HSA 600:41/01-028/17/03_49)
Local Contact: Terumo Singapore Pte Ltd
Contact no./Email: 6291 3603
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HSA 6004101-028-17-03_49 FSN_Redacted961 KB
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13 Nov 2017
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CLINITEK Novus®-to-Atellica® UAS 800 Rack Handler, Siemens Healthcare Diagnostics, Inc. (HSA 600:41/01-022/17/30_38)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA6004101-022-17-30_38 FSN16 KB
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13 Nov 2017
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Infant/Child Reduced Energy Defibrillation Electrodes, Physio-Control (HSA 600:41/01-056/17/05_35)
Local Contact: Gold Lite Pte Ltd
Contact no./Email: 6273 0487
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HSA 6004101-056-17-05_35 FSN_Redacted226 KB
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10 Nov 2017
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Covidien Puritan Bennett 980 Series Ventilator, Covidien Ilc (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 Customer Communication Letter79 KB
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10 Nov 2017
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Integrity, Elekta Limited (HSA 600:41/01-101/17/09_19)
Local Contact: Elekta Pte Ltd
Contact no./Email: 6221 2322 / Elekta_Global_PMS@elekta.com
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HSA 6004101-101-17-09_19 FSN_Redacted296 KB
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08 Nov 2017
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Alinity Hq Analyzer, Abbott GmbH & Co. KG (HSA 600:41/01-005/17/22_69)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8290 / FSN_enquiry@abbott.com
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HSA 6004101-005-17-22_69 FSN112 KB
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06 Nov 2017
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MONOCLONAL MOUSE ANTI-HUMAN CDX2, CLONE DAK-CDX2, Dako North America Inc (HSA 600:41/01-086/17/02_67)
Local Contact: SPD Scientific Pte Ltd
Contact no./Email: 6303 9877
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HSA 6004101-086-17-02_67 FSN_Redacted486 KB
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06 Nov 2017
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BiPAP A40, Respironics Inc. (HSA 600:41/01-317/17/01_25)
Local Contact: MedwoRx International Pte Ltd
Contact no./Email: 6853 3623
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HSA 6004101-317-17-01_25 FSN120 KB
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06 Nov 2017
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ELUVIATM 150MM AND INNOVATM 180MM & 200MM STENT SYSTEMS, Boston Scientific Corporation (HSA 600:41/01-007/17/09_18)
Local Contact: Boston Scientific Asia Pacific Pte Ltd.
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-17-09_18 FSN_Redacted3167 KB
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03 Nov 2017
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cobas MRSA/SA Nucleic acid test, Roche Molecular Systems, Inc (HSA 600:41/01-016/17/18_61)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-17-18_61 FSN335 KB
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02 Nov 2017
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Somatom Definition, Definition AS/Edge/Flash/Force, Siemens Healthcare GmbH (HSA 600:41/01-022/17/29_64)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-17-29_64 FSN_Redacted1938 KB
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02 Nov 2017
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VITEK 2 GP ID Card, bioMérieux SA (HSA 600:41/01-146/17/12_23)
Local Contact: Biomerieux Singapore Pte Ltd
Contact no./Email: 6801 6706
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HSA 6004101-146-17-12_23 FSN833 KB
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01 Nov 2017
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Fabius with Auxilliary Common Gas Outlet (ACGO), Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/17/05_62)
Local Contact: Draeger Singapore Pte Ltd
Contact no./Email: 6872 9288
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HSA 6004101-063-17-05_62 FSN_Redacted3873 KB
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13 Oct 2017
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VITEK® 2 Gram-Positive (GP) Identification (ID) Test Kit, bioMérieux, Inc. (HSA 600:41/01-146/17/11_69)
Local Contact: BioMerieux Singapore Pte Ltd
Contact no./Email: 6801 6700
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HSA 6004101-146-17-11_69 FSN Update781 KB
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