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DATE OF
NOTIFICATION
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TITLE
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FSN
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30 Dec 2015
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VerifyNow Aspirin Test Kits, Accumetrics Inc (HSA 600:41/01-246/15/01_34)
Local Contact: Harmoni Prima Medika Pte Ltd
Contact no./Email: 67496738
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HSA 6004101-246-15-01_34 FSN3132 KB
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30 Dec 2015
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CardioCall ECG Event Recorder, Spacelabs Healthcare Ltd (HSA 600:41/01-029/15/02_44)
Local Contact: Spacelabs Healthcare Pte Ltd
Contact no./Email: 68536300
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HSA 6004101-029-15-02_44 FSN74 KB
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30 Dec 2015
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Mavig Monitor suspensions installed on INNOVA 2000, INNOVA X100/IQ, INNOVA X1X1IQ, Advantx LCV+, Advantx LCA, Advantx LCLP+, Advantx LCN+ fluoroscopic imaging systems, GE Medical Systems SCS (HSA 600:41/01-010/15/25_52)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668
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HSA 6004101-010-15-25_52 FSN85 KB
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30 Dec 2015
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Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems, GE Medical Systems LLC (HSA 600:41/01-010/15/24_43)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668
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HSA 6004101-010-15-24_43 FSN71 KB
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29 Dec 2015
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Concerto Basic Shower Trolley, ArjoHuntleigh AB (HSA 600:41/01-065/15/01_51)
Local Contact: ArjoHuntleigh Singapore Pte Ltd
Contact no./Email: 62933387
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HSA 6004101-065-15-01_51 FSN68 KB
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28 Dec 2015
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Multiple dental abutment products and accessories, Biomet 3i (HSA 600:41/01-181/15/03_35)
Local Contact: Asia Implant Support and Services
Contact no./Email: 62232229
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HSA 6004101-181-15-03_35 FSN534 KB
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28 Dec 2015
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Nucleotron MicroSelection V3 remote controlled radionuclide applicator system, Nucletron B.V. (HSA 600:41/01-101/15/11_40)
Local Contact: Elekta Pte Ltd
Contact no./Email: 62212322
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HSA 6004101-101-15-11_40 FSN142 KB
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28 Dec 2015
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MOSAIQ, IMPAC Medical System Inc (HSA 600:41/01-101/15/10_36)
Local Contact: Elekta Pte Ltd
Contact no./Email: 62212322
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HSA 6004101-101-15-10_36 FSN117 KB
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28 Dec 2015
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Drive Gas Check Valve used with Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, and Avance CS2 Anesthesia devices, Datex-Ohmeda Inc (HSA 600:41/01-010/15/23_41)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668
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HSA 6004101-010-15-23_41 FSN77 KB
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24 Dec 2015
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Battery Power Line II Battery Oscillator, Synthes GmbH (HSA 600:41/01-002/15/62_37)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276459
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HSA 6004101-002-15-62_37 FSN801 KB
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24 Dec 2015
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Syngo Plaza, Siemens AG (HSA 600:41/01-022/15/64_25)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-15-64_25 FSN859 KB
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24 Dec 2015
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D10 Rack Loader, Bio-Rad Laboratories Inc (HSA 600:41/01-027/15/06_24)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: jenny_tok@bio-rad.com
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HSA 6004101-027-15-06_24 FSN414 KB
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24 Dec 2015
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Antimicrobial Susceptibility Testing Disc - QD15 Quiupristin/Dalfopristin, Oxoid Limited (HSA 600:41/01-178/15/06_31)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 64999992
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HSA 6004101-178-15-06_31 FSN75 KB
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22 Dec 2015
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Nova T Copper Intrauterine Device, Bayer Pharma AG (HSA 600:41/01-066/15/01_48)
Local Contact: Bayer South East Asia Pte Ltd
Contact no./Email: medinfo.singapore@bayer.com
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HSA 6004101-066-15-01_48 FSN36 KB
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22 Dec 2015
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miraDry System, Miramar Labs Inc (HSA 600:41/01-119/15/03_56)
Local Contact: Servicom Medical (Singapore) Pte Ltd
Contact no./Email: inquiry@servicom.com.sg
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HSA 6004101-119-15-03_56 FSN1350 KB
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21 Dec 2015
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SYNTHES® Universal Tibial and Femoral Nail System, Synthes GmbH (HSA 600:41/01-002/15/60_46)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135
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HSA 6004101-002-15-60_46 FSN2496 KB
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21 Dec 2015
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VITROS 250, VITROS 350, VITROS 5,1 FS, VITROS 4600 & VITROS 5600, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/61_22)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135
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HSA 6004101-002-15-61_22 FSN130 KB
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21 Dec 2015
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Allura Xper FD20 X-Ray Imaging System, Philips Medical Systems Nederland BV (HSA 600:41/01-026/15/42_55)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-15-42_55 FSN131 KB
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18 Dec 2015
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Datascope Cardiosave™ Intra-Aortic Balloon Pump, Datascope Corp (HSA 600:41/01-017/15/12_54)
Local Contact: IDS Medical Systems (Singapore) Pte Ltd
Contact no./Email: kennethow@idsmed.com
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HSA 6004101-017-15-12_54 FSN146 KB
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17 Dec 2015
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neXtra® Cutter Shaver Blades, DePuy Mitek (HSA 600:41/01-002/15/59_41)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276459
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HSA 6004101-002-15-59_41 FSN51 KB
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17 Dec 2015
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Certofix Quattro, B Braun Melsungen AG (HSA 600:41/01-012/15/10_51)
Local Contact: B Braun Singapore Pte Ltd
Contact no./Email: 62130933
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HSA 6004101-012-15-10_51 FSN47 KB
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17 Dec 2015
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Titanium Fluted Stem Extender, Howmedica Osteonics Corp (HSA 600:41/01-014/15/14_45)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: 65009507
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HSA 6004101-014-15-14_45 FSN64 KB
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17 Dec 2015
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Dengue NS1 Ag Strip, Bio-Rad Laboratories (HSA 600:41/01-027/15/05_20)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: jenny_tok@bio-rad.com
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HSA 6004101-027-15-05_20 FSN56 KB
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17 Dec 2015
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Oxylog 3000, 3000 plus & 2000 plus, Draegerwerk AG & Co KGaA (HSA 600:41/01-063/15/05_52)
Local Contact: Draeger Medical SEA Pte Ltd
Contact no./Email: Dsa.singapore@draeger.com
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HSA 6004101-063-15-05_52 FSN1714 KB
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16 Dec 2015
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ArmeoPower, Hocoma AG (HSA 600:41/01-286/15/01_35)
Local Contact: Hocoma Pte Ltd
Contact no./Email: 65130580
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HSA 6004101-286-15-01_35 FSN1136 KB
HSA 6004101-286-15-01_35 FSN2129 KB
HSA 6004101-286-15-01_35 FSN3128 KB
HSA 6004101-286-15-01_35 FSN4133 KB
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16 Dec 2015
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Perseus A500 Anesthesia Workstation, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/15/04_40)
Local Contact: Draeger Medical SEA Pte Ltd
Contact no./Email: 68729288
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HSA 6004101-063-15-04_40 FSN2349 KB
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16 Dec 2015
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Magnetom MR Systems and Biograph mMR, Siemens AG (for all MR systems except Magnetom Essenza); Siemens Shenzhen Magnetic Resonance Ltd (for Magnetom Essenza) (HSA 600:41/01-022/15/63_37)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-15-63_37 FSN339 KB
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16 Dec 2015
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Discovery MR750w; Discovery MR750, GE Medical Systems LLC (HSA 600:41/01-010/15/22_36)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668
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HSA 6004101-010-15-22_36 FSN243 KB
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16 Dec 2015
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PFNA, PFNA-II, DFN, & PFN Nails, PFNA & PFNA-II Blades, and PFNA & PFNA-II End Cap Extensions, Synthes GmbH (HSA 600:41/01-002/15/58_49)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135
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HSA 6004101-002-15-58_49 FSN84 KB
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15 Dec 2015
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Samarys Peek Anterior Cervical Cage, Scient'x SAS (HSA 600:41/01-198/15/01_33)
Local Contact: Scient’x Asia Pacific Pte Ltd
Contact no./Email: 64669460
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HSA 6004101-198-15-01_33 FSN280 KB
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14 Dec 2015
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Osteo-Site® Murphy Side Bevel Bone Biopsy Needle Set, Cook Incorporated(HSA 600:41/01-013/15/07_54)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 62877888
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HSA 6004101-013-15-07_54 FSN27 KB
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14 Dec 2015
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EchoTip® Ultra Endobronchial High Definition Ultrasound Needles, Cook Ireland Ltd (HSA 600:41/01-013/15/08_46)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 62877888
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HSA 6004101-013-15-08_46 FSN59 KB
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14 Dec 2015
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Soluscope Serie 4 PA, Soluscope SAS (HSA 600:41/01-017/15/10_56)
Local Contact: IDS Medical Systems (Singapore) Pte Ltd
Contact no./Email: kennethow@idsmed.com
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HSA 6004101-017-15-10_56 FSN158 KB
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14 Dec 2015
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Maquet FLOW-i Anesthesia System, Maquet Critical Care AB (HSA 600:41/01-017/15/11_29)
Local Contact: IDS Medical Systems (Singapore) Pte Ltd
Contact no./Email: kennethow@idsmed.com
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HSA 6004101-017-15-11_29 FSN28 KB
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14 Dec 2015
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Ambu AurGain Single Use Laryngeal Mask, Ambu A/S (HSA 600:41/01-056/15/03_45)
Local Contact: Gold Lite Pte Ltd
Contact no./Email: 62730487
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HSA 6004101-056-15-03_45 FSN387 KB
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14 Dec 2015
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Source Administration Sets (SAS), Bayer Medical Care (HSA 600:41/01-069/15/02_55)
Local Contact: O'Connor's Singapore Pte Ltd
Contact no./Email: 64737944
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HSA 6004101-069-15-02_55 FSN465 KB
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14 Dec 2015
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Arcadophta ® ARCOTANE C8F18 Purified Perfluoro-n-octane for Retinal Surgery, Arcadophta (HSA 600:41/01-104/15/01_18)
Local Contact: SurgiPro Pte Ltd
Contact no./Email: 68946038
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HSA 6004101-104-15-01_18 FSN3833 KB
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14 Dec 2015
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GlideScope Reusable GVL and AVL Blades, Verathon Medical Inc (HSA 600:41/01-076/16/03_43)
Local Contact: Radiance Medical Systems
Contact no./Email: 63162712
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HSA 6004101-076-16-03_43 FSN188 KB
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10 Dec 2015
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Synthes SynReam Medullary Reamer Head 13.5mm, Mathys Medical Ltd (HSA 600:41/01-002/15/57_53)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276459
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HSA 6004101-002-15-57_53 FSN2573 KB
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08 Dec 2015
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Terumo® Destination® Renal Guiding Sheath, Terumo Medical Corporation (HSA 600:41/01-028/15/01_44)
Local Contact: Terumo Medical Corporation
Contact no./Email: 62913603
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HSA 6004101-028-15-01_44 FSN79 KB
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08 Dec 2015
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da Vinci Xi Endoscope with Camera, 8mm, 0 deg and 30 deg, Intuitive Surgical (HSA 600:41/01-070/15/22_52)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 64776101
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HSA 6004101-070-15-22_52 FSN151 KB
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07 Dec 2015
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Beckman Coulter Unicel DxH 600 and 800 Coulter Cellular Analysis System, Beckman Coulter Inc. (HSA 600:41/01-052/15/11_61)|
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 63407126
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HSA 6004101-052-15-11_61 FSN1432 KB
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07 Dec 2015
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PuraStat, 3-D Matrix Europe SAS (HSA 600:41/01-282/15/02_51)
Local Contact: 3-D Matrix Asia Pte Ltd
Contact no./Email: 64083858
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HSA 6004101-282-15-02_51 FSN137 KB
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07 Dec 2015
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Absorb Bioresorbable Vascular Scaffold System and Absorb GT1 Bioresorbable Vascular Scaffold System, Abbott Vascular (HSA 600:41/01-005/15/06_43)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: FSN_Inquiry@abbott.com
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HSA 6004101-005-15-06_43 FSN133 KB
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07 Dec 2015
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Endo GIA Ultra Universal Stapler Handles, Covidien llc (HSA 600:41/01-046/15/09_41)
Local Contact: Covidien Private Limited
Contact no./Email: 64396974
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HSA 6004101-046-15-09_41 FSN1848 KB
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07 Dec 2015
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Masimo Rainbow Reusable Sensors for rainbow SET Devices with SpCO, SpO2, and SpMet, Masimo Corporation (HSA 600:41/01-061/15/01_50)
Local Contact: Masimo Asia Pacific Pte Ltd
Contact no./Email: 65216700
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HSA 6004101-061-15-01_50 FSN9051 KB
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04 Dec 2015
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PFN/PFNA Insertion Handle, Synthes GmbH (HSA 600:41/01-002/15/55_49)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 65-68276135
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HSA 6004101-002-15-55_49 FSN117 KB
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04 Dec 2015
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ADVIA 1200/1800/2400 Chemistry Systems, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/15/62_60)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
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HSA 6004101-022-15-62_60 FSN103 KB
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04 Dec 2015
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Kirschner Wire 1.6mm w/Drill Tip, L 200mm, sterile, Synthes GmbH (HSA 600:41/01-002/15/56_36)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 65-68276135
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HSA 6004101-002-15-56_36 FSN76 KB
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03 Dec 2015
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GYNECARE THERMACHOICE™ III Thermal Balloon Ablation Silicone Catheter, Ethicon, Inc. (HSA 600:41/01-002/15/54_33)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 65-68276135
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HSA 6004101-002-15-54_33 FSN461 KB
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03 Dec 2015
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Cellistypt, Cellistypt D-K and Cellistypt F, Synthesia, a.s. (HSA 600:41/01-012/15/09_37)
Local Contact: B. Braun Singapore Pte Ltd
Contact no./Email: 62130933
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HSA 6004101-012-15-09_37 FSN234 KB
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02 Dec 2015
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Brilliance 64, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT SP, Brilliance iCT, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/15/41_19)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-15-41_19 FSN108 KB
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02 Dec 2015
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Olympus Endoeye HD II, Olympus Winter & Ibe GmbH (HSA 600:41/01-004/15/07_29)
Local Contact: Olympus Singapore Pte Ltd
Contact no./Email: 68334219
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HSA 6004101-004-15-07_29 FSN357 KB
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01 Dec 2015
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Cytoluer Set, Baxter Healthcare SA, (HSA 600:41/01-001/15/04_25)
Local Contact: Baxter Healthcare (Asia) Pte Ltd
Contact no./Email: 65-68262616
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HSA 6004101-001-15-04_25 FSN79 KB
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01 Dec 2015
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Bond Polymer Refine Red Detection, Leica Biosystems Newcastle Ltd (HSA 600:41/01-126/15/05_59)
Local Contact: Leica Microsystems (SEA) Pte Ltd
Contact no./Email: 65505975
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HSA 6004101-126-15-05_59 FSN1750 KB
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