Date of Notification | Title | FSN |
|---|
28 Dec 2018 | Biomet Series A Standard Patella, Biomet Orthopedics (HSA 600:41/01-008/18/21_79)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com | HSA 6004101-008-18-21_79 FSN_Redacted [PDF, 237 KB] |
28 Dec 2018 | Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter, Biomet Orthopedics (HSA 600:41/01-008/18/20_74)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com | HSA 6004101-008-18-20_74 FSN_Redacted [PDF, 264 KB] |
27 Dec 2018 | Panocell-16, Immucor, Inc (HSA 600:41/01-033/18/07_69)
Local Contact: Biomed Diagnostics Pte Ltd
Contact no./Email: 6298 4347 / biomed.regulatory@biomed-global.com | HSA 6004101-033-18-07_69 FSN_Redacted [PDF, 43 KB] |
27 Dec 2018 | Covidien Emprint™ Percutaneous Antenna with Thermospere™ Technology, Covidien llc (HSA 600:41/01-046/18/13_63)
Local Contact: Covidien Private Limited
Contact no./Email: 6439 6974 | HSA 6004101-046-18-13_63 FSN_Redacted [PDF, 207 KB] |
27 Dec 2018 | Allura Xper FD2O OR Table and Azurion 7 M20 with a Trumpf Table, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/18/38_46)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact no./Email: 1800 744 5477 | HSA 6004101-026-18-38_46 FSN_Redacted [PDF, 336 KB] |
26 Dec 2018 | Intera, Omniva, Enterprise, Achieva, Achieva XR, Achieva Conversion, Panorama HFO, Ingenia, SmartPath to dStream, Multiva, Prodiva, MR-OR, MR-RT, MR-Linac, MR-Marlin systems, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/18/36_44)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477 | HSA 6004101-026-18-36_44 FSN_Redacted [PDF, 479 KB] |
26 Dec 2018 | Draeger VentStar breathing circuits, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/18/06_71)
Local Contact: Draeger Singapore Pte Ltd
Contact no./Email: 6872 9288 / draeger.sg@draeger.com | HSA 6004101-063-18-06_71 FSN_Redacted [PDF, 2741 KB] |
26 Dec 2018 | Philips Digital Diagnost C50 System, Philips Healthcare(Suzhou) Co. Ltd (HSA 600:41/01-026/18/37_50)
Local Contact: Philips Electronics(Singapore) Pte Ltd
Contact no./Email: 1800 744 5477 | HSA 6004101-026-18-37_50 FSN_Redacted [PDF, 9758 KB] |
24 Dec 2018 | Discovery NM 530c and Ventri Nuclear Medicine Systems, GE medical Systems Israel, Functional Imaging (HSA 600:41/01-010/18/29_37)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com | HSA 6004101-010-18-29_37 FSN_Redacted [PDF, 384 KB] |
23 Dec 2018 | Check-Flo Performer® Introducer, Cook Incorporated (HSA 600:41/01-013/18/14_63)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com | HSA 6004101-013-18-14_63 FSN_Redacted [PDF, 153 KB] |
21 Dec 2018 | Confirm Rx Insertable Cardiac Monitor, St Jude Medical Cardia Rhythm Management Division (HSA 600:41/01-005/18/27_52)
Local Contact: Abbott Medical (Singapore) Pte Ltd
Contact no./Email: 6914 8000 | HSA 6004101-005-18-27_52 FSN_Redacted [PDF, 53 KB] |
21 Dec 2018 | Alinity i Processing Module, Abbott GmbH & Co. KG (HSA 600:41/01-005/18/28_34)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: 6914 8000 / FSN_enquiry@abbott.com | HSA 6004101-005-18-28_34 FSN_Redacted [PDF, 379 KB] |
21 Dec 2018 | da Vinci Harmonic ACE Insert, Intuitive Surgical, Inc. (HSA 600:41/01-070/18/27_38)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regional.pms@transmedicgroup.com | HSA 6004101-070-18-27_38 FSN [PDF, 205 KB] |
21 Dec 2018 | EliA ANA Positive Control, Phadia AB (HSA 600:41/01-033/18/06_61)
Local Contact: Biomed Diagnostics Pte Ltd
Contact no./Email: 6298 4347 / biomed.regulatory@biomed-global.com | HSA 6004101-033-18-06_61 FSN_Redacted [PDF, 731 KB] |
20 Dec 2018 | Leica M220 F12, Leica Microsystems (Schweiz) AG (HSA 600:41/01-126/18/06_48)
Local Contact: Leica Instruments Singapore Pte Ltd
Contact no./Email: 6569 1828 | HSA 6004101-126-18-06_48 FSN_Redacted [PDF, 1580 KB] |
20 Dec 2018 | Cobas t 711 coagulation analyser, Roche Diagnostics GmbH (HSA 600:41/01-016/18/20_73)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com | HSA 6004101-016-18-20_73 FSN [PDF, 1914 KB] |
20 Dec 2018 | IV Pole Collar for Spectra Optia® and Trima Accel® Apheresis System, Terumo BCT Inc (HSA 600:41/01-155/18/02_62)
Local Contact: Terumo BCT Asia Pte Ltd
Contact no./Email: 6715 3778 / apac.communications@terumobct.com | HSA 6004101-155-18-02_62 FSN_Redacted [PDF, 213 KB] |
19 Dec 2018 | COULTER® EPICS® XL™ Flow Cytometer with System II Software, COULTER EPICS XL-MCL™ Flow Cytometer with System II Software, and FC 500 Series Flow Cytometers, Beckman Coulter Inc (HSA 600:41/01-052/18/07_49)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 6340 7126 | HSA 6004101-052-18-07_49 FSN_Redacted [PDF, 2074 KB] |
18 Dec 2018 | Philips Hemodynamic Application R1.0.1, Philips Medical Systems Nederland BV (HSA 600:41/01-026/18/35_62)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477 | HSA 6004101-026-18-35_62 FSN_Radacted [PDF, 1930 KB] |
17 Dec 2018 | Entuit Secure Gastrointestinal Suture Anchor Set, Cook Incorporated (HSA 600:41/01-013/18/13_48)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 68127400 / SNG-RegulatoryAffairs@CookMedical.com | HSA 6004101-013-18-13_48 FSN_Redacted [PDF, 155 KB] |
17 Dec 2018 | GE Healthcare MRI Systems, GE Healthcare (HSA 600:41/01-010/18/28_52)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com | HSA 6004101-010-18-28_52 FSN_Redacted [PDF, 476 KB] |
17 Dec 2018 | IBA Proteus ONE Proton Therapy System, Ion Beam Applications S.A. (HSA 600:41/01-070/18/26_76)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6102 / regional.pms@transmedicgroup.com | HSA 6004101-070-18-26_76 FSN_Redacted [PDF, 671 KB] |
17 Dec 2018 | StealthAir Percutaneous Pin Adapter, Medtronic Navigation, Inc (HSA 600:41/01-009/18/22_56)
Local Contact: Medtronic International Ltd.
Contact no./Email: 6439 5000 | HSA 6004101-009-18-22_56 FSN_Redacted [PDF, 193 KB] |
17 Dec 2018 | Modified ONFLEX mesh, Davol, Inc (HSA 600:41/01-050/18/08_44)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: 6580 5988 / Complaint.Singapore@crbard.com | HSA 6004101-050-18-08_44 FSN [PDF, 79 KB] |
17 Dec 2018 | Cardiovit MS-2007/2010/2015, Schiller AG (HSA 600:41/01-056/18/05_43)
Local Contact: Gold Lite
Contact no./Email: 6273 0487 | HSA 6004101-056-18-05_43 FSN_Redacted [PDF, 2960 KB] |
15 Dec 2018 | Cook Zenith Alpha Abdominal Endovascular Graft, William Cook Europe Aps (HSA 600:41/01-013/18/12_54)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com | HSA 6004101-013-18-12_54 FSN_Redacted [PDF, 536 KB] |
15 Dec 2018 | Cook Cirrus-14 Wire Guide, William Cook Europe Aps (HSA 600:41/01-013/18/09_66)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com | HSA 6004101-013-18-09_66 FSN_Redacted [PDF, 1322 KB] |
14 Dec 2018 | Accutrend BM-Lactate, Roche Diagnostics GmbH (HSA 600:41/01-016/18/18_75)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com | HSA 6004101-016-18-18_75 FSN [PDF, 462 KB] |
14 Dec 2018 | Medtronic HeartWare™ HVAD™ System Battery Charger, HeartWare (HSA 600:41/01-263/18/05_56)
Local Contact: Emergo Consulting Pte Ltd
Contact no./Email: 6854 7976 / SEAsiaVigilance@ul.com | HSA 6004101-263-18-05_56 FSN [PDF, 145 KB] |
14 Dec 2018 | PROXIMATE® Hemorrhoidal Circular Stapler, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/18/09_51)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 8304 | HSA 6004101-002-18-09_51 FSN_Redacted [PDF, 554 KB] |
14 Dec 2018 | MOSAIQ Radiation Oncology, Elekta, Inc. (HSA 600:41/01-101/18/06_63)
Local Contact: ELEKTA PTE. LTD.
Contact no./Email: 6221 2322 / Elekta_Global_PMS@elekta.com | HSA 6004101-101-18-06_63 FSN_Redacted [PDF, 1656 KB] |
14 Dec 2018 | cobas Bilirubin Total Gen 3, Lactate Gen 2 and Tinaquant IgM Gen 2, Roche Diagnostics GmbH (HSA 600:41/01-016/18/19_31)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com | HSA 6004101-016-18-19_31 FSN [PDF, 151 KB] |
14 Dec 2018 | Lag Screw 3.2mm Guide Pin, Smith & Nephew Inc (HSA 600:41/01-073/18/21_38)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-18-21_38 FSN [PDF, 98 KB] |
14 Dec 2018 | Journey DCF AP Femoral Cutting Block Size 3, Smith & Nephew Inc (HSA 600:41/01-073/18/20_71)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-18-20_71 FSN [PDF, 98 KB] |
12 Dec 2018 | Merci® Ballon Guide Catheter, Stryker Neurovascular (HSA 600:41/01-070/18/25_79)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6102 / regional.pms@transmedicgroup.com | HSA 6004101-070-18-25_79 FSN [PDF, 197 KB] |
12 Dec 2018 | Roche Diagnostics cobas c111 analyzer, Roche Diagnostics GmbH (HSA 600:41/01-016/18/17_70)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com | HSA 6004101-016-18-17_70_FSN [PDF, 108 KB] |
12 Dec 2018 | ATELLICA IM ANTI-THYROGLOBULIN (ATG) / ADVIA CENTAUR ANTI-THYROGLOBULIN (ATG), Siemens Healthcare Diagnostics Limited (HSA 600:41/01-022/18/29_57)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com | HSA 6004101-022-18-29_57_FSN [PDF, 7343 KB] |
12 Dec 2018 | Ingenia Elition S, Ingenia Elition X MR Systems, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/18/34_74)
Local Contact: Philips Electronic (Singapore) Pte Ltd
Contact no./Email: 18007445477 | HSA 6004101-026-18-34_74 FSN_Redacted [PDF, 462 KB] |
12 Dec 2018 | Legion Pressfit Stem, Smith & Nephew Inc (HSA 600:41/01-073/18/19_68)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-18-19_68 FSN [PDF, 98 KB] |
12 Dec 2018 | Ortho Clinical VITROS Chemistry Products VALP Reagent, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/18/18_73)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 6486 1151 | HSA 6004101-303-18-18_73 FSN [PDF, 367 KB] |
11 Dec 2018 | Olympus Airway Mobilescope, Ultrasonic Bronchofiberscope, Ultrasonic Bronchofibervideoscope, Bronchofiberscope, Bronchofibervideoscope, Rhino-Laryngo Videoscope, Olympus Medical Systems Corp; Olympus Optical Co. (HSA 600:41/01-004/18/03_44)
Local Contact: Olympus Singapore Pte Ltd
Contact no./Email: mes-ra.osp@olympus-ap.com | HSA 6004101-004-18-03_44 FSN_Redacted [PDF, 1522 KB] |
11 Dec 2018 | COBAS INTEGRA 400 plus, Roche Diagnostics GmbH (HSA 600:41/01-016/18/16_34)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com | HSA 6004101-016-18-16_34 FSN [PDF, 140 KB] |
11 Dec 2018 | Sekisui Automated Coagulation Analyzer CP3000, Sekisui Medical Co. Ltd. (HSA 600:41/01-005/18/26_70)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: 6914 8000 / FSN@enquiry@abbott.com | HSA 6004101-005-18-26_70 FSN [PDF, 198 KB] |
10 Dec 2018 | da Vinci® Xi/X Surgical System Arm Sensor for Intuitive Surgical® da Vinci® Xi® Endoscopic Control System(da Vinci Xi System) and Endoscopic instruments, Intuitive Surgical, Inc. (HSA 600:41/01-070/18/24_18)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6102 / regional.pms@transmedicgroup.com | HSA 6004101-070-18-24_18 FSN_Redacted [PDF, 184 KB] |
06 Dec 2018 | lnvivo Xper Flex Cardio Physiomonitoring System, INVIVO, a division of Philips Medical Systems (HSA 600:41/01-026/18/33_46)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact no./Email: 18007445477 | HSA 6004101-026-18-33_46 FSN_Redacted [PDF, 125 KB] |
06 Dec 2018 | Nanoknife Disposable Single Electrode Probes, AngioDynamic Inc (HSA 600:41/01-331/18/01_37)
Contact no./Email: regulatory_admin@elc-group.com | HSA 6004101-331-18-01_37 FSN_Redacted [PDF, 421 KB] |
05 Dec 2018 | VITROS Immunodiagnostic Products Myoglobin Calibrators, Ortho-Clinical Diagnostics (HSA 600:41/01-303/18/17_49)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 6486 1151 | HSA 6004101-303-18-17_49 FSN [PDF, 257 KB] |
04 Dec 2018 | Elekta Mosaiq, Elekta, Inc (HSA 600:41/01-101/18/05_76)
Local Contact: Elekta Pte. Ltd.
Contact no./Email: 6221 2322 / Elekta_Global_PMS@elekta.com | HSA 6004101-101-18-05_76 FSN_Redacted [PDF, 1684 KB] |
03 Dec 2018 | SD BIOLINE Chikungunya IgM, Standard Diagnostics Inc (HSA 600:41/01-111/18/02_23)
Local Contact: Unison Collaborative Pte Ltd
Contact no./Email: 6734 5577 / info@unicoll.com.sg | HSA 6004101-111-18-02_23 FSN_Redacted [PDF, 4710 KB] |
03Dec 2018 | multiFiltrate Pro, Frensenius Medical Care AG & Co. KGaA (HSA 600:41/01-062/18/03_50)
Local Contact: Frensenius Medical Care Singapore Pte Ltd
Contact no./Email: 6837 3113 / enquiry.SG@fmc-asia.com | HSA 6004101-062-18-03_50 FSN_Redacted [PDF, 2315 KB] |
