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DATE OF NOTIFICATION
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TITLE
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FSN
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31 Aug 2016
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TANDEM™ BIPOLAR HIP SYSTEM, Smith & Nephew Inc (HSA 600:41/01-073/16/24_52)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-16-24_52 FSN104 KB
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31 Aug 2016
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IMMULITE®, IMMULITE® 1000/ 2000/ 2000 Xpi, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/16/42_60)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-42_60 FSN102 KB
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31 Aug 2016
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Intraocular Lenses, Abbott Medical Optics, Inc (HSA 600:41/01-018/16/01_63)
Local Contact: AMO Singapore Pte Ltd
Contact no./Email: 68448833
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HSA 6004101-018-16-01_63 FSN251 KB
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30 Aug 2016
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Philips Brilliance 64 and Ingenuity CT/Core/Core 128, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/31_50)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 18007445477
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HSA 6004101-026-16-31_50 FSN126 KB
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29 Aug 2016
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Muller Hinton 2 agar + 5% sheep blood, BioMérieux SA (HSA 600:41/01-146/16/09_58)
Local Contact: Biomerieux Singapore Pte Ltd
Contact no./Email: 68016706
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HSA 6004101-146-16-09_58 FSN325 KB
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25 Aug 2016
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Thermo Scientific Oxoid CT1629B CAZ10 CEFTAZIDIME, Oxoid Limited (HSA 600:41/01-178/16/06_57)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: customerservice.mbdsingapore@thermofisher.com
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HSA 6004101-178-16-06_57 FSN125 KB
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25 Aug 2016
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EnCor® Needle Guide Insert 10G, SenoRx, Inc (HSA 600:41/01-050/16/05_36)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: complaints.singapore@crbard.com
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HSA 6004101-050-16-05_36 FSN96 KB
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25 Aug 2016
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ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c), Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/41_38)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-41_38 FSN89 KB
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25 Aug 2016
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OPTILENE 4/0 (1,5) 90CM 2XHRC22, B. Braun Surgical SA (HSA 600:41/01-012/16/08_44)
Local Contact: B. Braun Singapore Pte Ltd
Contact no./Email: 62130933
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HSA 6004101-012-16-08_44 FSN136 KB
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25 Aug 2016
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SIGNA Creator and SIGNA Explorer, GE Healthcare (Tianjin) Company Limited (HSA 600:41/01-010/16/13_40)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: scv@ge.com
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HSA 6004101-010-16-13_40 FSN281 KB
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25 Aug 2016
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BD Vacutainer® Push Button Blood Collection Set, Becton, Dickinson and Company (HSA 600:41/01-003/16/08_49)
Local Contact: Becton Dickinson Holdings Pte Ltd (BD)
Contact no./Email: 64322048
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HSA 6004101-003-16-08_49 FSN247 KB
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24 Aug 2016
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Sagittal Blade 18.0X.97X90MM, Stryker Instruments (HSA 600:41/01-014/16/11_35)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com
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HSA 6004101-014-16-11_35 FSN89 KB
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24 Aug 2016
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Bio-Rad EVOLIS Systems, DiaMed GmbH (HSA 600:41/01-027/16/10_07)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 64904262
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HSA 6004101-027-16-10_07 FSN439 KB
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23 Aug 2016
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Infant Warmer System, Ohmeda Medical (HSA 600:41/01-010/16/12_37)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: svc@ge.com
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HSA 6004101-010-16-12_37 FSN1041 KB
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23 Aug 2016
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Misago Self-Expanding Stent System, Terumo Corporation (HSA 600:41/01-028/16/05_33)
Local Contact: Terumo Singapore Pte Ltd
Contact no./Email: 62913603
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HSA 6004101-028-16-05_33 FSN67 KB
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22 Aug 2016
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Trident Universal Impactor/Positioner, Howmedica Osteonics Corp (HSA 600:41/01-014/16/10_45)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com
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HSA 6004101-014-16-10_45 FSN163 KB
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22 Aug 2016
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Hermann Gastronomy Dressing Set, Fresenius Kabi AG (HSA 600:41/01-020/16/01_19)
Local Contact: Fresenius Kabi (Singapore) Pte Ltd
Contact no./Email: 68372552
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HSA 6004101-020-16-01_19 FSN27 KB
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22 Aug 2016
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UniCel DxH 800 & DxH 600 Coulter Cellular Analysis System, Beckman Coulter Inc. (HSA 600:41/01-052/16/11_61)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 63407126
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HSA 6004101-052-16-11_61 FSN74 KB
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22 Aug 2016
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Waismed NIO Adult Intraosseous Device, WaisMed Limited (HSA 600:41/01-301/16/01_25)
Local Contact: EO Medical Pte Ltd
Contact no./Email: 61005060
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HSA 6004101-301-16-01_25 FSN3045 KB
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19 Aug 2016
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Roadrunner® UniGlide® Hydrophilic Wire Guide, Cook Incorporated (HSA 600:41/01-013/16/04_18)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 68127400
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HSA 6004101-013-16-04_18 FSN134 KB
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19 Aug 2016
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ATEC Canister used with ATEC vacuum-assisted breast biopsy systems, Hologic, Inc, (HSA 600:41/01-196/16/01_51)
Local Contact: Medical Imaging Systems Pte Ltd
Contact no./Email: 94359898
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HSA 6004101-196-16-01_51 FSN72 KB
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18 Aug 2016
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Syva Emit II Plus Opiate / Dimension Opiates / ADVIA Chemistry Opiate_2 Assays, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/40_59)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-40_59 FSN 190 KB
HSA 6004101-022-16-40_59 FSN 290 KB
HSA 6004101-022-16-40_59 FSN 390 KB
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18 Aug 2016
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Lyphochek Coagulation Control, Bio-Rad Laboratories Diagnostics Group (HSA 600:41/01-027/16/09_60)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 64904262
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HSA 6004101-027-16-09_60 FSN171 KB
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17 Aug 2016
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HYDRO LeMaitre Valvulotome, LeMaitre Vascular, Inc (HSA 600:41/01-057/16/04_09)
Local Contact: Somnotec (S) Pte Ltd
Contact no./Email: info@somnotec.net
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HSA 6004101-057-16-04_09 FSN466 KB
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17 Aug 2016
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Snowden-Pencer Diamond-Flex Circular Retractor, Angled, 40mm, 5mm, Carefusion (HSA 600:41/01-145/16/01_56)
Local Contact: Medquest Marketing Pte Ltd
Contact no./Email: 68051250
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HSA 6004101-145-16-01_56 FSN4095 KB
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16 Aug 2016
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Fluorocell PLT, Sysmex Corporation (HSA 600:41/01-032/16/05_57)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 6221 3629 / RA@sysmex-ap.com
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HSA 6004101-032-16-05_57 FSN1084 KB
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16 Aug 2016
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Blue Ortho Exactech® GPS System – GPS Station V2, Blue Ortho (HSA 600:41/01-257/16/02_48)
Local Contact: Exactech Pte Ltd
Contact no./Email: 6273 0091
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HSA 6004101-257-16-02_48 FSN264 KB
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16 Aug 2016
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VITROS Chemistry Products GLU/LAC/TRIG/URIC slides, Ortho-Clinical Diagnostic Inc (HSA 600:41/01-002/16/34_58 )
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: bsee@its.jnj.com
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HSA 6004101-002-16-34_58 FSN135 KB
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16 Aug 2016
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RAPIDPoint® 400/405/500 Systems, RAPIDLab® 1200 Systems IPOC 16-0211, Siemens Healthcare Diagnostics, Inc. (HSA 600:41/01-022/16/39_57)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-39_57 FSN22 KB
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15 Aug 2016
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IS4000 EndoWrist Stapler 45, Intuitive Surgical, Inc. (HSA 600:41/01-070/16/18_41)
Local Contact: Transmedic Pte Ltd
Contact no./Email: regulatory@transmedicgroup.com
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HSA 6004101-070-16-18_41 FSN451 KB
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15 Aug 2016
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Astral 100 and Astral 150, ResMed Ltd (HSA 600:41/01-275/16/01_54)
Local Contact: RESMED ASIA OPERATIONS PTY LIMITED (SINGAPORE BRANCH)
Contact no./Email: 6572 5936
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HSA 6004101-275-16-01_54 FSN240 KB
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15 Aug 2016
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LIFEPAK CR Plus/ LIFEPAK EXPRESS Automatic External Defibrillator(s), PHYSIO-CONTROL, INC. (HSA 600:41/01-056/16/06_49)
Local Contact: Gold Lite Pte Ltd
Contact no./Email: 6273 0487
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HSA 6004101-056-16-06_49 FSN28 KB
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15 Aug 2016
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YSIO, YSIO MAX, MULTIX FUSION, Siemens Healthcare GmbH (HSA 600:41/01-022/16/38_44)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-38_44 FSN1631 KB
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15 Aug 2016
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Merge Eye Care PACS, Merge Healthcare Incorporated (HSA 600:41/01-110/16/03_36)
Local Contact: Mandarin Opto-Medic Co Pte Ltd
Contact no./Email: manopt@mandarinoptomedic.com
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HSA 6004101-110-16-03_36 FSN641 KB
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15 Aug 2016
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Merge Eye Station and Eye Care PACS, Merge Healthcare Incorporated (HSA 600:41/01-110/16/02_35)
Local Contact: Mandarin Opto-Medic Co Pte Ltd
Contact no./Email: manopt@mandarinoptomedic.com
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HSA 6004101-110-16-02_35 FSN715 KB
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15 Aug 2016
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UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Beckman Coulter Inc. (HSA 600:41/01-052/16/10_34)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: khwong@beckman.com
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HSA 6004101-052-16-10_34 FSN75 KB
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15 Aug 2016
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STIMPOD NMS410 / NMS450 Nerve Stimulator, Xavant Technology (HSA 600:41/01-017/16/07_43)
Local Contact: IDS Medical Systems (S) Pte Ltd
Contact no./Email: kennethow@Idsmed.com
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HSA 6004101-017-16-07_43 FSN327 KB
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15 Aug 2016
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Molnlycke Caesarean Section Pack & Molnlcyke GEH C-Section Pack, Molnlycke Health Care AB (HSA 600:41/01-228/16/01_40)
Local Contact: Molnlycke Health Care Asia-Pacific Pte Ltd
Contact no./Email: suki.lim@molnlycke.com
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HSA 6004101-228-16-01_40 FSN82 KB
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15 Aug 2016
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AcrySof IQ IOL with ULTRASERT"' delivery system, Alcon Laboratories Inc. (HSA 600:41/01-135/16/04_46)
Local Contact: Alcon Pte Ltd
Contact no./Email: 6722 1255
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HSA 6004101-135-16-04_46 FSN101 KB
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15 Aug 2016
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QUANTUM BLUE CALPROTECTIN ASSAY, 25 tests, BUHLMANN Laboratories AG (HSA 600:41/01-137/16/01_38)
Local Contact: All Eights (Singapore) Pte Ltd
Contact no./Email: 6288 6388
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HSA 6004101-137-16-01_38 FSN416 KB
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12 Aug 2016
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Exactech Total Knee Arthroplasty Software Application, Blue Ortho (HSA 600:41/01-257/16/01_19)
Local Contact: Exactech Pte Ltd
Contact no./Email: 6273 0091
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HSA 6004101-257-16-01_19 FSN 1263 KB
HSA 6004101-257-16-01_19 FSN 2220 KB
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12 Aug 2016
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Symbia E systems, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/16/37_33)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-37_33 FSN6846 KB
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12 Aug 2016
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Hill-Rom Progressa bed System with European (OIML), Hill-Rom Inc (HSA 600:41/01-182/16/01_25)
Local Contact: Hill-Rom Services Private Limited
Contact no./Email: huifang.zhu@hill-rom.com
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HSA 6004101-182-16-01_25 FSN742 KB
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12 Aug 2016
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ADVIA Centaur Systems Calibrator U, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/36_24)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-36_24 FSN170 KB
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11 Aug 2016
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Spacelab Healthcare ULTRAVIEW SL ™ MONITOR SYSTEM, Spacelabs Healthcare, Inc (HSA 600:41/01-029/16/02_18)
Local Contact: SpaceLabs Healthcare Pte Ltd
Contact no./Email: 6853 6306
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HSA 6004101-029-16-02_18 FSN44 KB
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8 Aug 2016
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CADstream, Merge Healthcare (HSA 600:41/01-010/16/11_08)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: svc@ge.com
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HSA 6004101-010-16-11_08 FSN488 KB
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8 Aug 2016
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PRIMEDIC AkuPak LITE, METRAX GmbH (HSA 600:41/01-029/16/01_17)
Local Contact: SpaceLabs Healthcare Pte Ltd
Contact no./Email: steven.tan@spacelabs.com
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HSA 6004101-029-16-01_17 FSN109 KB
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5 Aug 2016
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Elekta MOSAIQ, IMPAC Medical Systems Inc (HSA 600:41/01-101/16/06_09)
Local Contact: Elekta Pte Ltd
Contact no./Email: Elekta_Global_PMS@elekta.com
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HSA 6004101-101-16-06_09 FSN53 KB
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4 Aug 2016
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Ethicon Mersilene™ Tape, Ethicon Inc (HSA 600:41/01-002/16/33_56)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: bsee@its.jnj.com
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HSA 6004101-002-16-33_56 FSN180 KB
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3 Aug 2016
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Whipknot Soft Tissue Cinch #5 Sutures, Smith & Nephew Inc (HSA 600:41/01-073/16/23_48)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: Singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-16-23_48 FSN258 KB
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3 Aug 2016
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Medtronic EnVeo R Delivery Catheter System, Medtronic CoreValve LLC (HSA 600:41/01-009/16/14_54)
Local Contact: Medtronic International Limited
Contact no./Email: shezhiyan@medtronic.com
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HSA 6004101-009-16-14_54 FSN65 KB
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3 Aug 2016
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CDX2, Dako Denmark A/S (HSA 600:41/01-086/16/01_23)
Local Contact: SPD Scientific Pte Ltd
Contact no./Email: Dako.dkvigilance@agilent.com
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HSA 6004101-086-16-01_23 FSN18 KB
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3 Aug 2016
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Etest Colistin CO 256 WW, bioMérieux SA (HSA 600:41/01-146/16/08_22)
Local Contact: Biomerieux Singapore Pte Ltd
Contact no./Email: 6801 6706
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HSA 6004101-146-16-08_22 FSN400 KB
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3 Aug 2016
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Macopharma Blood Bags with CPD and LCR Filters, MacoPharma (HSA 600:41/01-033/16/06_52)
Local Contact: Biomed Diagnostics Pte Ltd
Contact no./Email: regulatory@biomed.com.sg
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HSA 6004101-033-16-06_52 FSN315 KB
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2 Aug 2016
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Lotus Valve System, Boston Scientific Corporation (HSA 600:41/01-007/16/05_63)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: Singapore_FSCA_Query@bsci.com
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HSA 6004101-007-16-05_63 FSN3343 KB
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2 Aug 2016
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da Vinci® Xi™ EndoWrist Stapler, Intuitive Surgical Inc. (HSA 600:41/01-070/16/17_51)
Local Contact: Transmedic Pte Ltd
Contact no./Email: regulatory@transmedicgroup.com
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HSA 6004101-070-16-17_51 FSN466 KB
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2 Aug 2016
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ImmunoCAP Specific IgE Control H lot CYYAC, Phadia AB (HSA 600:41/01-033/16/05_20)
Local Contact: Biomed Diagnostics Pte Ltd
Contact no./Email: 65087663
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HSA 6004101-033-16-05_20 FSN115 KB
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1 Aug 2016
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ADVIA Centaur PSA, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/35_07)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-16-35_07 FSN32 KB
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1 Aug 2016
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Philips IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, Philips Medizin Systeme Boblingen GmbH (HSA 600:41/01-026/16/30_41)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-16-30_41 FSN127 KB
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27 Jul 2016
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Thermo Scientific Oxoid Columbia Blood Agar Base CM0331 (B,R,S,T,U), Oxoid Limited (HSA 600:41/01-178/16/05_60)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 64999993
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HSA 6004101-178-16-05_60 FSN175 KB
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26 Apr 2016
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Cell Saver Elite disposable processing kits, Haemonetics Corporation (HSA 600:41/01-070/16/11_29)
Local Contact: Transmedic Pte Ltd
Contact no./Email: regulatory@transmedicgroup.com
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HSA 6004101-070-16-11_29 FSN272 KB
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03 Dec 2015
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HU35, HCU20, HCU30, HCU40 Systems, Maquet Cardiopulmonary AG (HSA 600:41/01-017/15/09_35)
Local Contact: IDS Medical Systems (Singapore) Pte Ltd
Contact no./Email: 66907380
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HSA 6004101-017-15-09_35 FSN1320 KB
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