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Date of Notification
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Title
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FSN
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29 Feb 2016
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BioMatrix Flex and BioMatrix NeoFlex Drug Eluting Coronary Stent System, Biosensors Europe SA (HSA 600:41/01-223/16/01_43)
Local Contact: Biosensors Interventional Technologies Pte Ltd
Contact no./Email: fieldsafetynotice@biosensors.com
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HSA 6004101-223-16-01_43 FSN1743 KB
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29 Feb 2016
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WECK® AutoEndo5® Hem-o-lok® 5mm Automatic Endoscopic Hem-o-lok Applier, Weck Closure Systems (HSA 600:41/01-139/16/03_46)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact no./Email: 64393043
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HSA 6004101-139-16-03_46 FSN389 KB
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29 Feb 2016
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Modulith SLX-F2, Storz Medical AG (HSA 600:41/01-133/16/02_25)
Local Contact: Karl Storz Endoscopy Singapore Sales Pte Ltd
Contact no./Email: 69229170
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HSA 6004101-133-16-02_25 FSN354 KB
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29 Feb 2016
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On-Board Imager® with CBCT, Varian Medical Systems, Inc (HSA 600:41/01-058/16/02_18)
Local Contact: Varian Medical Systems Pacific Inc
Contact no./Email: 68870028
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HSA 6004101-058-16-02_18 FSN70 KB
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29 Feb 2016
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Artis Zee and Artis Zeego, Siemens Healthcare GmbH (HSA 600:41/01-022/16/09_52)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-09_52 FSN645 KB
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26 Feb 2016
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BRAHMS Free beta-hCG Kryptor, BRAHMS GmbH (HSA 600:41/01-138/16/01_60)
Local Contact: Dyamed Biotech Pte Ltd
Contact no./Email: 68481028
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HSA 6004101-138-16-01_60 FSN2685 KB
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26 Feb 2016
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Berichrom® Antithrombin III, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-032/16/02_59)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 62213629
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HSA 6004101-032-16-02_59 FSN21 KB
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26 Feb 2016
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Various Mid-Urethral Sling products, Boston Scientific Corporation (HSA 600:41/01-007/16/01_41)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 64188888
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HSA 6004101-007-16-01_41 FSN37 KB
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25 Feb 2016
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ORTHO VISION® Analyzers and ORTHO VISION® Max Analyzers, Ortho-Clinical Diagnostic Inc (HSA 600:41/01-002/16/07_57)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135
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HSA 6004101-002-16-07_57 FSN66 KB
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24 Feb 2016
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AQT90 FLEX Test Kit Box and CAL Cartridge, Radiometer Medical Aps (HSA 600:41/01-219/16/02_38)
Local Contact: Radiometer S.E.A Pte Ltd
Contact no./Email: 63896027
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HSA 6004101-219-16-02_38 FSN25 KB
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24 Feb 2016
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TRACOE larynx stoma button, Tracoe Medical GmbH (HSA 600:41/01-149/16/01_49)
Local Contact: I:Emedics Pte Ltd
Contact no./Email: 67470166
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HSA 6004101-149-16-01_49 FSN116 KB
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24 Feb 2016
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BARD TRUGUIDE® Disposable Coaxial Biopsy Needles, Bard Peripheral Vascular Inc (HSA 600:41/01-050/16/01_33)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: 65805988
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HSA 6004101-050-16-01_33 FSN234 KB
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24 Feb 2016
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PVC Trocar catheter CH 24, Redax S.p.A. (HSA 600:41/01-017/16/01_45)
Local Contact: IDS Medical Systems (Singapore) Pte Ltd
Contact no./Email: 66907339
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HSA 6004101-017-16-01_45 FSN31 KB
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23 Feb 2016
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Nellix Endo Vascular Aneurysm Sealing System, Endologix International Holdings B.V. (HSA 600:41/01-148/16/01_29)
Local Contact: DKSH Singapore Pte Ltd
Contact no./Email: 66597402
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HSA 6004101-148-16-01_29 FSN319 KB
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23 Feb 2016
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VITROS® Immunodiagnostic Products Total β-hCG II Reagent Packs & Calibrators, Ortho-Clinical Diagnostic Inc(HSA 600:41/01-002/16/06_34)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135
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HSA 6004101-002-16-06_34 FSN156 KB
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22 Feb 2016
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Artis Zee & Artis Q/Q.zen, Siemens Healthcare GmbH (HSA 600:41/01-022/16/06_56)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-06_56 FSN74 KB
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22 Feb 2016
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AXIOM Artis & Artis zee systems, Siemens Healthcare GmbH (HSA 600:41/01-022/16/07_56)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-07_56 FSN76 KB
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22 Feb 2016
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VESA 75/ 100 adaptation with rotation, ITD GmbH (HSA 600:41/01-073/16/07_18)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: Singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-16-07_18 FSN290 KB
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22 Feb 2016
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Liko Universal SlingBar 350/ 450/ 600, Liko AB (HSA 600:41/01-076/16/02_17)
Local Contact: Radiance Medical Systems
Contact no./Email: 63162712
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HSA 6004101-076-16-02_17 FSN537 KB
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22 Feb 2016
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VIDAS TOXO IgM, Biomerieux SA (HSA 600:41/01-146/16/01_31)
Local Contact: Biomerieux Singapore Pte Ltd
Contact no./Email: 68016706
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HSA 6004101-146-16-01_31 FSN401 KB
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22 Feb 2016
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AcuFocus KAMRA ACI 7000 Corneal Inlay, AcuFocus Inc (HSA 600:41/01-239/16/01_25)
Local Contact: Eye Lens Pte Ltd
Contact no./Email: admin@eyelens.sg
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HSA 6004101-239-16-01_25 FSN88 KB
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19 Feb 2016
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Physio-Control QUIK-COMBO pacing/ defibrillation/ ECG electrodes, Physio-Control Inc (HSA 600:41/01-056/16/03_48)
Local Contact: Gold Lite Pte Ltd
Contact no./Email: 62730487
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HSA 6004101-056-16-03_48 FSN76 KB
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18 Feb 2016
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Medical Head Lamp, Bistos co Ltd (HSA 600:41/01-291/16/01_54)
Local Contact: Walen Tec Asia Pte Ltd
Contact no./Email: 66362875
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HSA 6004101-291-16-01_54 FSN62 KB
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17 Feb 2016
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Universal Battery Charger II, Synthes GmbH (HSA 600:41/01-002/16/04_45)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135
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HSA 6004101-002-16-04_45 FSN160 KB
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17 Feb 2016
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VITROS 5600 Integrated Systems, Ortho-Clinical Diagnostic Inc (HSA 600:41/01-002/16/05_24)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135
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HSA 6004101-002-16-05_24 FSN114 KB
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17 Feb 2016
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Respironics Trilogy 100 System, Philips Respironics Inc (HSA 600:41/01-290/16/01_44)
Local Contact: Elite Homecare Pte Ltd
Contact no./Email: sleep.easy.sg@gmail.com
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HSA 6004101-290-16-01_44 FSN2497 KB
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16 Feb 2016
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TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia Lighting and Video Systems, TRUMPF Medizin Systeme GmbH (HSA 600:41/01-279/16/01_37)
Local Contact: Bio-Pointe Pte Ltd
Contact no./Email: 67488911
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HSA 6004101-279-16-01_37 FSN183 KB
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16 Feb 2016
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ARROW® Super Arrow-Flex® Percutaneous Sheath Introducer Set, Arrow International (HSA 600:41/01-139/16/01_51)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact no./Email: 64393046
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HSA 6004101-139-16-01_51 FSN122 KB
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16 Feb 2016
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Trilogy 100, Trilogy 200, Respironics, Inc. (HSA 600:41/01-087/16/01_40)
Local Contact: Scanmed Technology (S) Pte Ltd
Contact no./Email: 68723660
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HSA 6004101-087-16-01_40 FSN221 KB
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16 Feb 2016
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CDI® H/S Cuvette, Terumo Cardiovascular System Corporation (HSA 600:41/01-028/16/01_36)
Local Contact: Terumo Singapore Pte Ltd
Contact no./Email: 62913603
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HSA 6004101-028-16-01_36 FSN267 KB
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16 Feb 2016
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Borehole Port, Christoph Miethke GmbH & Co. KG (HSA 600:41/01-012/16/01_49)
Local Contact: B. Braun Singapore Pte Ltd
Contact no./Email: 62130933
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HSA 6004101-012-16-01_49 FSN340 KB
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16 Feb 2016
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Aisys CS2 and upgraded Aisys anesthesia devices, Datex-Ohmeda, Inc (HSA 600:41/01-010/16/03_41)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668
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HSA 6004101-010-16-03_41 FSN84 KB
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15 Feb 2016
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Oxoid Streptococcal Grouping Kit, Oxoid Limited (HSA 600:41/01-178/16/01_22)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 64999992
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HSA 6004101-178-16-01_22 FSN110 KB
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15 Feb 2016
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VESA 75/100 adaptation with rotation, ITD GmbH (HSA 600:41/01-133/16/01_18)
Local Contact: Karl Storz Endoscopy Singapore Sales Pte Ltd
Contact no./Email: 69229150
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HSA 6004101-133-16-01_18 FSN443 KB
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15 Feb 2016
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Glidescope Titanium Single-Use Video Laryngoscope Blades, Verathon Medical Inc (HSA 600:41/01-076/16/01_19)
Local Contact: Radiance Medical Systems
Contact no./Email: 63162712
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HSA 6004101-076-16-01_19 FSN418 KB
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15 Feb 2016
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Arietta 60 & Arietta 70, Hitachi Aloka Medical, Ltd (HSA 600:41/01-054/16/01_33)
Local Contact: Hitachi Medical Systems (S) Pte Ltd
Contact no./Email: 66020110
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HSA 6004101-054-16-01_33 FSN119 KB
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15 Feb 2016
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Liquichek Specialty Immunoassay Control kit, Bio-Rad Laboratories (HSA 600:41/01-027/16/01_61)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 64904262
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HSA 6004101-003-16-01_61 FSN35 KB
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15 Feb 2016
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3.0T GEMflex Coil, GE Medical Systems LLC (HSA 600:41/01-010/16/02_25)
Local Contact:GE Healthcare Pte Ltd
Contact no./Email:62777668
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HSA 6004101-010-16-02_25 FSN75 KB
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12 Feb 2016
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Panocell, Capture-R Ready-ID and Capture-R Ready-ID Extend II, Immucor Inc (HSA 600:41/01-033/16/02_60)
Local Contact: Biomed Diagnostics Pte Ltd
Contact no./Email: 62984347
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HSA 6004101-033-16-02_60 FSN123 KB
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12 Feb 2016
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MitraClip Clip Delivery System, Evalve, LLC (DBA Abbott Vascular Inc.) (HSA 600:41/01-005/16/03_17)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 62700760
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HSA 6004101-005-16-03_17 FSN731 KB
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12 Feb 2016
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Sekisui Diagnostics Acetaminophen L3K Assay, Sekisui Diagnostics P.E.I. Inc (HSA 600:41/01-005/16/02_58)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 68850000
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HSA 6004101-005-16-02_58 FSN126 KB
HSA 6004101-005-16-02_58 FSN2756 KB
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10 Feb 2016
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ADVIA Centaur Calibrator E, Siemens Healthcare Diagnostic Inc. (HSA 600:41/01-022/16/05_38)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-05_38 FSN314 KB
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10 Feb 2016
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Artis One System, Siemens Shenzhen Magnetic Resonance Ltd (HSA 600:41/01-022/16/04_46)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-04_46 FSN552 KB
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04 Feb 2016
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BIOSURE Ratcheted Driver, Smith & Nephew Inc (HSA 600:41/01-073/16/06_45)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: Singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-16-06_45 FSN77 KB
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04 Feb 2016
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Extraction Screw for PFNA Blade, Synthes GmbH (HSA 600:41/01-002/16/03_44)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135
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HSA 6004101-002-16-03_44 FSN70 KB
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03 Feb 2016
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Endobon®-Xenograft Granules 0.5 ml/1ml/2ml/5ml/8ml, Biomet 3i (HSA 600:41/01-181/16/01_41)
Local Contact: Asia Implant Support & Services
Contact no./Email: 62232229
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HSA 6004101-181-16-01_41 FSN433 KB
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03 Feb 2016
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Digital Radiography X-Ray System DX-D 100, Agfa HealthCare N.V. (HSA 600:41/01-184/16/01_52)
Local Contact: Agfa HealthCare Singapore Pte Ltd
Contact no./Email: 62140622
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HSA 6004101-184-16-01_52 FSN105 KB
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02 Feb 2016
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Trilogy 100, Trilogy 200, Garbin, Garbin Plus, Trilogy O2, Trilogy 202 and Trilogy EC Respironies, Inc. (HSA 600:41/01-287/16/01_40)
Local Contact: VitalAire-Avattvon Singapore Pte Ltd
Contact no./Email: info@VitalAire-Avattvon.com
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HSA 6004101-287-16-01_40 FSN4981 KB
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01 Feb 2016
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TWINFIX 5.0 AB Suture Anchor w/Two 38” Ultrabraid Suture Needles and Threaded Dilator, Respironies, Inc. (HSA 600:41/01-073/16/05_36)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: Singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-16-05_36 FSN 61 KB
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01 Feb 2016
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Endobutton CL BTB Sterile 30mm, Smith & Nephew Inc (HSA 600:41/01-073/16/04_49)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: Singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-16-04_49 FSN54 KB
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