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Date of Notification
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Title
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FSN
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29 Dec 2017
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ADVIA Centaur CP, XP, XPT BNP and TSH3-UL assay, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/17/34_23)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-17-34_23 FSN100 KB
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29 Dec 2017
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W & H Implantmed Surgical Drive Unit, W & H Dentalwerk Burmoos GmbH (HSA 600:41/01-164/17/01_52)
Local Contact: HealthBiz Resource Pte Ltd
Contact no./Email: 6481 1610 / inquiry@healthbiz.com.sg
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HSA 6004101-164-17-01_52 FSN91 KB
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29 Dec 2017
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Cook Transseptal Needle, Cook Incorporated (HSA 600:41/01-013/17/11_62)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com
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HSA 6004101-013-17-11_62 FSN_Redacted1117 KB
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29 Dec 2017
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Cook Guardia Access Nano Embryo Transfer Catheter, Cook Incorporated (HSA 600:41/01-013/17/10_52)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com
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HSA 6004101-013-17-10_52 FSN_Redacted108 KB
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28 Dec 2017
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ROCHE COBAS U 601 URINE ANALYZER and ROCHE COBAS U 701 MICROSCOPY ANALYZER, Roche Diagnostics GmbH (HSA 600:41/01-016/17/21_57)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-17-21_57 FSN559 KB
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28 Dec 2017
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Phadia ImmunoCAP Specific IgE Fluoreenzyme immunoassay, Phadia AB (HSA 600:41/01-033/17/05_70)
Local Contact: Biomed Diagnostics Pte Ltd
Contact no./Email: 6298 4347 / biomed.regulatory@biomed-global.com
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HSA 6004101-033-17-05_70 FSN_Redacted278 KB
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26 Dec 2017
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LIFEPAK 20e, Physio-Control, Inc (HSA 600:41/01-056/17/07_51)
Local Contact: Gold Lite Pte Ltd
Contact no./Email: 6273 0487
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HSA 6004101-056-17-07_51 HSN_Redacted432 KB
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22 Dec 2017
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ARROW AGB+ PRESSURE INJECTABLE MULTI-LUMEN CVC KIT, Arrow International, Inc (HSA 600:41/01-139/17/06_49)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact no./Email: 6438 2380
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HSA 6004101-139-17-06_49 FSN49 KB
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22 Dec 2017
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GUIDER SOFTIP™ XF GUIDE CATHETERS, Boston Scientific Corporation (HSA 600:41/01-070/17/26_49)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-17-26_49 FSN276 KB
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22 Dec 2017
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LigaSure Maryland Jaw Sealer/Dividers, Covidien llc (HSA 600:41/01-046/17/12_50)
Local Contact:Covidien Pte Ltd
Contact no./Email: 64396933
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HSA 6004101-046-17-12_50 FSN_Redacted1865 KB
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22 Dec 2017
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Hemoglobin A1c (HbA1c) Reagent Kit, Abbott Laboratories (HSA 600:41/01-005/17/28_69)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com
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HSA 6004101-005-17-28_69 FSN220 KB
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21 Dec 2017
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Allura Xper systems, Philips Medical Systems Nederland BV (HSA 600:41/01-026/17/21_56)
Local Contact:Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-17-21_56 FSN_Redacted449 KB
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21 Dec 2017
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CARESCAPE R860 ventilator, Datex-Ohmeda Inc (HSA 600:41/01-010/17/07_35)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-17-07_35 FSN_Redacted285 KB
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21 Dec 2017
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2.7MM S-T CORTEX SCREW 16MM, Smith & Nephew, Inc. (HSA 600:41/01-073/17/20_56)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-17-20_56 FSN173 KB
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21 Dec 2017
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ELECSYS BRAHMS PCT, Roche Diagnostics GmbH (HSA 600:41/01-016/17/19_69)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-17-19_69 FSN340 KB
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21 Dec 2017
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Hematoxylin II and Horseradish Peroxidase reagents (refer FSN for affected Kits name), Ventana Medical Systems, Inc. (HSA 600:41/01-016/17/20_38)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-17-20_38 FSN464 KB
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21 Dec 2017
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Philips CORE, and CORE Mobile systems with software version v3.5, Volcano Corporation (HSA 600:41/01-070/17/25_68)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-17-25_68 FSN_Redacted1232 KB
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21 Dec 2017
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Lullaby RESUS Plus Systems, Ohmeda Medical (HSA 600:41/01-010/17/06_71)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-17-06_71 FSN_Redacted513 KB
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20 Dec 2017
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SpyScope DS Access and Delivery Catheter, Boston Scientific Corporation (HSA 600:41/01-007/17/15_54)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-17-15_54 FSN_Redacted1666 KB
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20 Dec 2017
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BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16
Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/17/20_46)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-17-20_46 FSN_Redacted306 KB
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20 Dec 2017
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Cardiac Resynchronization Therapy pacemakers (VALITUDE™, VISIONIST™) and defibrillators (CHARISMA™ , MOMENTUM™, RESONATE™, VIGILANT™, AUTOGEN™, DYNAGEN™, INOGEN™, ORIGEN™)
Boston Scientific Corporation (HSA 600:41/01-007/17/14_43)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-17-14_43 FSN_Redacted945 KB
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20 Dec 2017
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Taylor Spatial Frame Website Software, Smith & Nephew, Inc. (HSA 600:41/01-073/17/19_52)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-17-19_52 FSN_Redacted199 KB
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19 Dec 2017
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ClearSight Heart Reference Sensor, Edwards Lifesciences (HSA 600:41/01-060/17/02_50)
Local Contact: Edwards Lifesciences (Asia) Pte.Ltd
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HSA 6004101-060-17-02_50 FSN_Redacted2462 KB
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19 Dec 2017
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PACEMAKERS (ACCOLADE™, PROPONENT™, ESSENTIO™, ALTRUA™ 2), CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (VALITUDE™, VISIONIST™)
Boston Scientific Corporation (HSA 600:41/01-007/17/13_51)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-17-13_51 FSN_Redacted408 KB
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19 Dec 2017
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Boston Scientific Uphold LITE Vaginal Support System & Boston Scientific Solyx SIS System, Boston Scientific Corporation (HSA 600:41/01-007/17/12_18)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-17-12_18 FSN_Redacted311 KB
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19 Dec 2017
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Atellica UAS 800 analyzer, Siemens Healthcare Diagnostics, Inc. (HSA 600:41/01-022/17/33_34)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-17-33_34 FSN35 KB
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19 Dec 2017
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UNIVERSAL WEDGE SCREW, 9MM X 25MM
ACL DISPOSABLE PACK BONE-TENDON-BONE
PKG. DISPOSABLE STRYKEFLOW S/I TIP
PKG., ASSY., SUCTION / IRRIGATOR 2
PKG., ASSY., STRYKEFLOW 2 WITH TIP
STRYKER AHTO TUBE SET PACKAGING
STRYKER AHTO TUBE SET WITH TIP PACKAGING; Stryker Endoscopy (HSA 600:41/01-014/17/08_54)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com
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HSA 6004101-014-17-08_54 FSN_Redacted137 KB
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19 Dec 2017
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Covidien Signia Power Handles, Covidien llc (HSA 600:41/01-046/17/11_63)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6933
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HSA 6004101-046-17-11_63 FSN_Redacted2092 KB
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19 Dec 2017
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Trevo XP Provue Procedure Pack, Concentric Medical, Inc (HSA 600:41/01-070/17/24_71)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-17-24_71 FSN141 KB
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19 Dec 2017
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IMMULITE®/IMMULITE® 1000 IMMULITE® 2000/IMMULITE® 2000 XPi Assays, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/17/32_31)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-17-32_31 FSN87 KB
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18 Dec 2017
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Abbott CELL-DYN Emerald 22 Instrument, Abbott Laboratories Diagnostics Division (HSA 600:41/01-005/17/27_34)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: 6914 8290 / FSN_enquiry@abbott.com
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HSA 6004101-005-17-27_34 FSN96 KB
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18 Dec 2017
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Trevo XP Provue System, TREVO XP PROVUE RETRIEVER 4X20 + TREVO PRO 18 MC KIT, Concentric Medical, Inc (HSA 600:41/01-070/17/23_46)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-17-23_46 FSN36 KB
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18 Dec 2017
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Cordis SMART Flex Vascular Stent System, Cordis Cashel (HSA 600:41/01-307/17/02_50)
Local Contact: Cardinal Health Singapore 225 Pte Ltd
Contact no./Email: 6230 2362
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HSA 6004101-307-17-02_50 FSN_Redacted301 KB
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15 Dec 2017
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Abbott Architect DHEA-S Assay, Abbott GmbH & Co. KG (HSA-600-41/01-005/17/26_70)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com
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HSA 6004101-005-17-26_70 FSN205 KB
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14 Dec 2017
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ETEST® Teicoplanin 256 (TP) SPB and Foam packaging, BioMerieux S.A (HSA 600:41/01-146/17/13_69)
Local Contact:BioMerieux Singapore Pte Ltd
Contact no./Email: 6801 6700
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HSA 6004101-146-17-13_69 FSN451 KB
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13 Dec 2017
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CUTICERIN Surgical Dressing, Smith & Nephew Medical Limited (HSA 600:41/01-073/17/18_48)
Local Contact:Smith & Nephew Pte Limited
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-17-18_48 FSN117 KB
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13 Dec 2017
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Artis Zee and Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/17/31_44)
Local Contact:Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-17-31_44 FSN_Redacted120 KB
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13 Dec 2017
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Bone Cement and Optipac, Biomet France (HSA 600:41/01-008/17/20_63)
Local Contact:Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-17-20_63 FSN_Redacted342 KB
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13 Dec 2017
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Persona Stemmed Tibial Plate, Zimmer Inc. (HSA 600:41/01-008/17/19_51)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-17-19_51 FSN_Redacted65 KB
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13 Dec 2017
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Philips Ingenuity TF PET/CT Imaging System, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/17/19_44)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-17-19_44 FSN_Redacted606 KB
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13 Dec 2017
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da Vinci Xi EndoWrist Stapler 45, 30, 30 curved tip, Intuitive Surgical Inc. (HSA 600:41/01-070/17/22_36)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-17-22_36 FSN469 KB
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12 Dec 2017
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Malecot Nephrostomy Catheter Set and Re-Entry™ Malecot Nephrostomy Catheter Set, Boston Scientific Corporation (HSA 600:41/01-007/17/11_49)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 64188888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-17-11_49 FSN_Redacted155 KB
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12 Dec 2017
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Proteus 235, Ion Beam Applications S.A. (HSA 600:41/01-070/17/21_64)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6737 1945 / regulatory@transmedicgroup.com
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HSA 6004101-070-17-21_64 FSN2_Redacted1339 KB
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11 Dec 2017
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ARCHITECT C4000 CUVETTE SEGMENT ARCHITECT, C8000 CUVETTE SEGMENT, ARCHITECT C16000 CUVETTE SEGMENT, Abbott Laboratories (HSA 600:41/01-005/17/25_67)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: 6914 8290 / FSN_enquiry@abbott.com
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HSA 6004101-005-17-25_67 FSN405 KB
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08 Dec 2017
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Alaris Syringe Module Model 8110 and Alaris PCA Module Model 8120, CareFusion 303 Inc (HSA 600:41/01-003/17/21_35)
Local Contact: Becton Dickinson Holdings Pte Ltd (BD)
Contact no./Email: 6432 2011
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HSA 6004101-003-17-21_35 FSN_Redacted1748 KB
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08 Dec 2017
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Aquagel 5gms, Ecolab Ltd (HSA 600:41/01-318/17/01_35)
Local Contact: Kemimac (S) Pte Ltd
Contact no./Email: 6259 0553
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HSA 6004101-318-17-01_35 FSN_Redacted134 KB
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07 Dec 2017
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1•DAY ACUVUE® MOIST™ Brand, Johnson & Johnson Vision Care Inc (HSA 600:41/01-002/17/15_37)
Local Contact: Johnson & Johnson Pte Ltd (Vision Care Division)
Contact no./Email: 6918 7295
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HSA 6004101-002-17-15_37 FSN_Redacted1439 KB
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07 Dec 2017
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1.0MM DRILL BIT MINI-QUICK CONNECT and FAST 1.1MM DRILLBIT MINIQUICK, Biomet Orthopaedics (HSA 600:41/01-008/17/18_37)
Local Contact: Zimmer Pte Ltd
Contact no./Email: Tel: 68547222 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-17-18_37 FSN_Redacted84 KB
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06 Dec 2017
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Respironics Bipap A40, Respironics Inc. (HSA 600:41/01-199/17/01_71)
Local Contact: Junnimed Services Pte Ltd
Contact no./Email: 6546 7737 / sales@junnimed.com
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HSA 6004101-199-17-01_71 FSN_Redacted184 KB
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06 Dec 2017
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Various highly polished hip and knee implants, Zimmer, Inc. (HSA 600:41/01-008/17/17_18)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-17-17_18 FSN_Redacted758 KB
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06 Dec 2017
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Automated Digital Cell Morphology Analyzer DI-60, CellaVision AB (HSA 600:41/01-032/17/06_31)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 6221 3629 / RA@sysmex-ap.com
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HSA 6004101-032-17-06_31 FSN_Redacted1829 KB
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06 Dec 2017
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Elekta Synergy, Elekta Synergy S, Elekta Infinity, Elekta Axxesse, Elekta VersaHD, Elekta Limited (HSA 600:41/01-101/17/10_19)
Local Contact: Elekta Pte. Ltd.
Contact no./Email: 6221 2322 / Elekta_Global_PMS@elekta.com
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HSA 6004101-101-17-10_19 FSN 1_Redacted458 KB
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06 Dec 2017
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MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLATE-RM/LL-SZ 7, MAKO Surgical Corp (HSA 600:41/01-070/17/20_64)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-17-20_64 FSN98 KB
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05 Dec 2017
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Qisda InnoSight Diagnostic Ultrasound System, QISDA Corporation (HSA 600:41/01-026/17/18_52)
Local Contact:Philips Electronics (S) Singapore Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-17-18_52 FSN_Redacted31 KB
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04 Dec 2017
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Boston Scientific Wallstent Endoprostheses with Unistep Plus Delivery System, Boston Scientific Corporation (HSA 600:41/01-007/17/10_40)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-17-10_40 FSN_Redacted794 KB
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04 Dec 2017
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ARROW® CVC, MAC, PI CVC, PICC, and PSI Kits, Arrow International, Inc (HSA 600:41/01-139/17/05_48)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact no./Email: 6439 3043
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HSA 6004101-139-17-05_48 FSN26 KB
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01 Dec 2017
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Thermo Scientific Oxoid Brilliance Staph 24, Oxoid Limited (HSA 600:41/01-178/17/08_61)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6499 9999 / cs.mbd.sg@thermofisher.com
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HSA 6004101-178-17-08_61 FSN_Redacted153 KB
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01 Dec 2017
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Cook Vital-Port® Vascular Access System, Cook Medical (HSA 600:41/01-013/17/09_49)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com
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HSA 6004101-013-17-09_49 FSN_Redacted64 KB
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05 Oct 2017
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Bio-Rad DiaMed ID-Card LISS/Coombs, DiaMed GmbH (HSA 600:41/01-027/17/08_58)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
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HSA 6004101-027-17-08_58 FSN update_Redacted2469 KB
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