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Date of Notification
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Title
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FSN
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30 Apr 2019
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Oxford Unicompartmental Knee Drill Guides (Phase 3/Domed Lateral), Biomet UK Ltd (HSA 600:41/01-008/19/02_79)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-19-02_79 FSN_Redacted302 KB
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29 Apr 2019
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MitraClip® XTR Clip Delivery System, Abbott Vascular (HSA 600:41/01-005/19/15_18)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8000 / FSN_Enquiry@abbott.com
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HSA 6004101-005-19-15_18 FSN_Redacted199 KB
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29 Apr 2019
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SOLOPATH® Re-collapsible Balloon Access System, and SOLOPATH® Balloon Expandable TransFemoral System, Terumo Medical Corporation (HSA 600:41/01-028/19/02_51)
Local Contact: Terumo Singapore Pte Ltd
Contact no./Email: 6291 3603
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HSA 6004101-028-19-02_51 FSN_Redacted2366 KB
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29 Apr 2019
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MAHURKAR and Argyle acute hemodialysis catheters, Covidien llc (HSA 600:41/01-046/19/04_46)
Local Contact: Covidien Private Limited
Contact no./Email: 6439 6974
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HSA 6004101-046-19-04_46 FSN_Redacted3267 KB
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29 Apr 2019
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Alinity hq Analyzer, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/14_31)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com
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HSA 6004101-005-19-14_31 FSN248 KB
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29 Apr 2019
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Philips PageWriter TC30 Cardiograph, Philips Medical Systems (HSA 600:41/01-026/19/13_68)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-19-13_68 FSN_Redacted1542 KB
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26 Apr 2019
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Defibrillation Electrode SCHILLER, Schiller AG (HSA 600:41/01-056/19/02_18)
Local Contact: Gold Lite Pte Ltd
Contact no./Email: 6273 0487
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HSA 6004101-056-19-02_18 FSN223 KB
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25 Apr 2019
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Philips SureSigns VS3/VS4 Monitors, Philips Medical Systems (HSA 600:41/01-026/19/12_43)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-19-12_43 FSN_Redacted742 KB
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25 Apr 2019
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Rotablator Rotational Atherectomy System and Labsystem PRO, Boston Scientific Corporation (HSA 600:41/01-007/19/04_46)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_ Query@bsci.com
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HSA 6004101-007-19-04_46 FSN_Redacted100 KB
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25 Apr 2019
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Getinge 86/88 Series Washer Disinfector, Getinge Disinfection AB (HSA 600:41/01-224/19/03_64)
Local Contact: Getinge South East Asia Pte Ltd
Contact no./Email: 6296 1992
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HSA 6004101-224-19-03_64 FSN_Redacted190 KB
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22 Apr 2019
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ABBOTT ALINITY C PROCESSING MODULE, CUVETTE SEGMENT, Abbott GmbH&Co KG (HSA 600:41/01-005/19/13_57)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com
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HSA 6004101-005-19-13_57 FSN465 KB
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22 Apr 2019
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Brizio Membrane Oxygenator and Venous Reservoir, Nipro Medical Ltda (HSA 600:41/01-233/19/01_52)
Local Contact: Nipro Asia Pte Ltd
Contact no./Email: 6588 2281 / qara@nipro.com.sg
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HSA 6004101-233-19-01_52 FSN_Redacted6241 KB
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18 Apr 2019
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Samsung GM85 Digital Mobile X-Ray Imaging Systems, Samsung Electronics Co., Ltd. (HSA 600:41/01-087/19/02_76)
Local Contact: SCANMED TECHNOLOGY (S) PTE LTD
Contact no./Email: 6872 3660 / info@scanmed.com.sg
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HSA 6004101-087-19-02_76 FSN_Redacted114 KB
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18 Apr 2019
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Evis Lucera Duodenovideoscope, Evis Exera Duodenovideoscope, Olympus Medical Systems Corp. (HSA 600:41/01-004/19/02_44)
Local Contact: Olympus Singapore Pte Ltd
Contact no./Email: mes-ra.osp@olympus-ap.com
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HSA 6004101-004-19-02_44 FSN_Redacted1257 KB
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17 Apr 2019
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Schiller Medical DEFIGARD Touch 7, Schiller Medical (HSA 600:41/01-340/19/02_71)
Local Contact: Evolve Medical Pte Ltd
Contact no./Email: 6250 7108 / ra@evolvemedical.com.sg
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HSA 6004101-340-19-02_71 FSN_Redacted125 KB
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16 Apr 2019
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DERMABONDTM PRINEOTM SKIN CLOSURE SYSTEM, Ethicon LLC (HSA 600:41/01-002/19/08_44)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 6717
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HSA 6004101-002-19-08_44 FSN_Redacted283 KB
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16 Apr 2019
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Mentor MemoryGel Siltex Silicone Gel filled breast implant, Mentor Medical Systems B.V. (HSA 600:41/01-002/19/07_76)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 6717
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HSA 6004101-002-19-07_76 FSN_Redacted202 KB
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15 Apr 2019
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CARDIOHELP EMERGENCY DRIVE, Maquet Cardiopulmonary GmbH (HSA 600:41/01-224/19/02_77)
Local Contact: Getinge South East Asia Pte Ltd
Contact no./Email: 6296 1992
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HSA 6004101-224-19-02_77 FSN_Redacted244 KB
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15 Apr 2019
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Artisan™ 70cm 2x8 Surgical Lead Kit, 35cm and 55cm 8 Contact Extension Kits, Linear™ 3-4 50cm and 70cm 8 Contact Lead Kit, Precision™ M8 Adapter, 15cm, Boston Scientific Corporation (HSA 600:41/01-007/19/03_51)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-19-03_51 FSN_Redacted138 KB
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15 Apr 2019
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Alinity i Processing Module, Abbott GmbH & Co. KG (HSA 600:41/01‐005/19/12_23)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: FSN@enquiry@abbott.com
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HSA 6004101-005-19-12_23 FSN276 KB
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11 Apr 2019
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VITROS Chemistry Products CK Slides on VITROS 250 or VITROS 350 Chemistry Systems, Ortho-Clinical Diagnostics (HSA 60041/01-303/19/04_61)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 6486 1151
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HSA 6004101-303-19-04_61 FSN215 KB
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11 Apr 2019
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Dornier Standard Diode and Nd:YAG Lightguides, Dornier MedTech GmbH (HSA 600:41/01-161/19/01_38)
Local Contact: Dornier MedTech Asia Pte Ltd
Contact no./Email: 6572 6056 / asiaregulatory@dornier.com
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HSA 6004101-161-19-01_38 FSN_Redacted2414 KB
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11 Apr 2019
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NAVIO INSTRUMENT KIT UK/BE/FR/DE/IT, Smith & Nephew, Inc. (HSA 600:41/01-073/19/07_35)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-19-07_35 FSN75 KB
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10 Apr 2019
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AurigaTM 30 and AurigaTM XL 4007 Laser System, Boston Scientific Corporation (HSA 600:41/01-007/19/02_66)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-19-02_66 FSN_Redacted238 KB
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09 Apr 2019
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Artis Zee and Arties Q/Q.zen Systems, Siemens Healthcare GmbH (HSA 600:41/01-022/19/09_54)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-19-09_54 FSN_Redacted419 KB
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09 Apr 2019
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Algisite M Surgical Dressing, Smith & Nephew Medical Ltd (HSA 600:41/01-073/19/06_37)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-19-06_37 FSN131 KB
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09 Apr 2019
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Philips IntelliVue MX40, Philips Medical Systems (HSA 600:41/01-026/19/11_48)
Local Contact: Philips Electronic (Singapore) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-19-11_48 FSN (2)_Redacted341 KB
This FSN is an update to the original FSN published in Apr 2019.
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09 Apr 2019
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Philips IntelliVue MX40, Philips Medical Systems (HSA 600:41/01-026/19/11_48)
Local Contact: Philips Electronic (Singapore) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-19-11_48 FSN_Redacted1489 KB |
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08 Apr 2019
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ARCHITECH HbA1c Calibrators, ARCHITECT Intact PTH Calibrators, ARCHITECT Intact PTH Controls, Multichem S Plus (assayed) Level 1, Multichem S Plus (assayed) Level 2, ARCHITECT STAT High Sensitive Troponin-I Calibrators, ARCHITECT STAT High Sensitive Troponin-I Control, Alinity i Anti-TPO Calibrators, ARCHITECT Sirolimus Calibrators, ABBOTT GmbH & Co. KG, Abbott Ireland Diagnostics Division, Abbott Laboratories Diagnostics Division, Technopath Manufacturing Ltd (HSA 600:41/01-005/19/11_69)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com
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HSA 6004101-005-19-11_69 FSN294 KB
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05 Apr 2019
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Lyphochek Specialty Immunoassay Control, Bio-Rad Laboratories Inc (HSA 600:41/01-027/19/01_59)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
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HSA 6004101-027-19-01_59 FSN112 KB
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05 Apr 2019
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T7 Cannulated Driver AO and T7 Driver Solid AO, Biomet Orthopedics (HSA 600:41/01-008/19/01_18)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-19-01_18 FSN_Redacted250 KB
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04 Apr 2019
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MobileDiagnost wDR, Philips Medical Systems (HSA 600:41/01-026/19/10_74)
Local Contact: Philips Electronic (Singapore) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-19-10_74 FSN_Redacted141 KB
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04 Apr 2019
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GE Healthcare Detector Mounting Screws for Nuclear Medicine Systems (Discovery NM 630, Discovery NM/CT 670 CZT, Discovery NM/CT 670 DR,Discovery NM/CT 670 ES, Optima NM/CT 640, NM 830, NM/CT 850, NM/CT 860, NM/CT 870 CZT, NM/CT 870 DR), GE Medical Systems Israel (HSA 600:41/01-010/19/09_38)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-19-09_38 FSN_Redacted113 KB
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04 Apr 2019
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MyLab Six and MyLab Gamma, Esaote SpA (HSA 600:41/01-263/19/01_48)
Local Contact: Emergo Consulting Pte. Ltd
Contact no./Email: 6854 7976 / SEAsiaVigilance@ul.com
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HSA 6004101-263-19-01_48 FSN_Redacted156 KB
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04 Apr 2019
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FRED Easy defibrillator, Schiller Medical (HSA 600:41/01-340/19/01_46)
Local Contact: Evolve Medical Pte Ltd
Contact no./Email: 6250 7108 / ra@evolvemedical.com. sg
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HSA 6004101-340-19-01_46 FSN_Redacted413 KB
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03 Apr 2019
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enFlow Disposable Cartridge & enFlow Disposable Cartridge with IV Extension Set, Vyaire Medical Inc. (HSA 600:41/01-199/19/02_71)
Local Contact: Junnimed Services Pte Ltd
Contact no./Email: 6546 7737 / sales@junnimed.com
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HSA 6004101-199-19-02_71 FSN_Redacted367 KB
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03 Apr 2019
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PROXIMATE ILS Curved and Straight Intraluminal Stapler and ENDOPATH ILS Endoscopic Curved Intraluminal Stapler, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/19/06_43)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 8304
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HSA 6004101-002-19-06_43 FSN_Redacted328 KB
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03 Apr 2019
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Philips Ingenia Ambition S and Philips Ingenia Ambition X, Philips Medical Systems Nederland B.V (HSA 600:41/01-026/19/09_56)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-19-09_56 FSN_Redacted192 KB
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03 Apr 2019
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HeartMate 3™ Left Ventricular Assist System (LVAS) kit, Thoratec Corporation (HSA 600:41/01-339/19/01_52)
Local Contact: Abbott Medical (Singapore) Pte Ltd
Contact no./Email: 6914 8000
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HSA 6004101-339-19-01_52 FSN_Redacted160 KB
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02 Apr 2019
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Drill Mini-Trephination 2.0mm, Medtronic Xomed (HSA 600:41/01-009/19/05_51)
Local Contact: Medtronic International Limited
Contact no./Email: 6439 5000
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HSA 6004101-009-19-05_51 FSN_Redacted130 KB
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02 Apr 2019
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Bilirubin direct Gen 2, cobas c701/702, Roche Diagnostics GmbH (HSA 600:41/01-016/19/05_69)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-19-05_69 FSN129 KB
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02 Apr 2019
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The Infinity® Acute Care System and Standalone Infinity® M540 patient monitor, Draeger Medical Systems, Inc. (HSA 600:41/01-063/19/03_56)
Local Contact: Draeger Singapore Pte Ltd
Contact no./Email: 6872 9288 / draeger.sg@draeger.com
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HSA 6004101-063-19-03_56 FSN_Redacted850 KB
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18 July 2018
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Philips SureSigns Patient Monitors, VS3 System,VS4 Vital Signs Monitor, and VSV Vital Signs Viewer, Philips Medical Systems (HSA 600:41/01-026/18/21_54)
Local Contact: Philips Electronics (S) Pte Ltd
Contact No./Email: 1800 744 5477
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HSA 6004101-026-18-21_54 FSN_Redacted157 KB
This FSN is an update to the original FSN published in Jul 2018.
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