|
Date of Notification
|
Title
|
FSN
|
|
31 July 2018
|
Zimmer® Natural Nail™ System Tibial Nail - Yellow 8.3mm, Zimmer Inc. (HSA 600:41/01-008/18/12_50)
Local Contact: Zimmer Pte Ltd
Contact No./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
|
HSA 6004101-008-18-12_50 FSN_Redacted282 KB
|
|
31 July 2018
|
Panocell-10, Immucor Inc (HSA 600:41/01-033/18/03_70)
Local Contact: Biomed Diagnostics Pte Ltd
Contact No./Email: 6298 4347 / biomed.regulatory@biomed-global.com
|
HSA 6004101-033-18-03_70 FSN_Redacted47 KB
|
|
31 July 2018
|
IH-QC 5, DiaMed GmbH (HSA 600:41/01-02718/10_57)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact No./Email: 6490 4262
|
HSA 6004101-027-18-10_57_FSN_Redacted459 KB
|
|
30 July 2018
|
Abbott ARCHITECT EBV Assay Panel, Abbott GmbH & Co. KG (HSA:600:41/01-005/18/10_69)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact No./Email: 6941 8000 / FSN@enquiry@abbott.com
|
HSA 6004101-005-18-10_69 FSN100 KB
|
|
27 July 2018
|
Proteus 235, Ion Beam Applications S. A. (HSA 600:41/01-070/18/15_77)
Local Contact: Transmedic Pte Ltd
Contact No./Email: 6477 6101 / regulatory.pms@transmedicgroup.com
|
HSA 6004101-070-18-15_77 FSN_Redacted1000 KB
|
|
27 July 2018
|
Durex Real Feel Condom, Reckitt Benckiser Healthcare (UK) Ltd (HSA 600:41/01-327/18/01_37)
Local Contact: Reckitt Benckiser (Singapore) Pte Ltd
Contact No./Email: 1800 875 0770 / careline.sg@rb.com
|
HSA 6004101-327-18-01_37 FSN_Redacted553 KB
|
|
27 July 2018
|
Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit, MAKO Surgical Corp (Stryker) (HSA 600:41/01-070/18/16_18)
Local Contact: Transmedic Pte Ltd
Contact No./Email: 6477 6101 / regulatory@transmedicgroup.com
|
HSA 6004101-070-18-16_18 FSN_Redacted184 KB
|
|
27 July 2018
|
Artis Q and Artis Pheno Systems, Siemens Healthcare GmbH (HSA 600:41/01-022/18/18_45)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
|
HSA 6004101-022-18-18_45 FSN_Redacted1075 KB
|
|
26 July 2018
|
ADVIA Centaur CKMB Calibrator and Master Curve Material (MCM) , and Atellica IM CKMB Calibrator and Master Curve Material (MCM), Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/18/17_57)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
|
HSA 6004101-022-18-17_57_FSN206 KB
|
|
25 July 2018
|
Samsung Digital X-ray System GC80, GC85A, GC70, Samsung Electronics Co Limited (HSA 600:41/01-087/18/01_74)
Local Contact: Scanmed Technology (S) Pte Ltd
Contact No./Email: 6872 3660; info@scanmed.com.sg
|
HSA 6004101-087-18-01_74 FSN_Redacted364 KB
|
|
24 July 2018
|
1 Day ACUVUE® MOIST, Johnson & Johnson Vision Care Inc (HSA 600:41/01-002/18/07_63)
Local Contact: Johnson & Johnson Pte Ltd (Vision Care Division)
Contact No./Email: 6918 7295
|
HSA 6004101-002-18-07_63 FSN_Redacted366 KB
|
|
24 July 2018
|
Orthopat Reservoirs, Haemonetics Corporation (HSA 600:41/01-070/18/14_38)
Local Contact: Transmedic Pte Ltd
Contact No./Email: 6477 6101 / regional.pms@transmedicgroup.com
|
HSA 6004101-070-18-14_38 FSN_Redacted522 KB
|
|
23 July 2018
|
Gentle Thread PLGA Round Head, 7x20mm and Gentle Thread PLGA Full Thread, 10x30mm, Biomet Orthopaedics (HSA 600:41/01-008/18/11_51)
Local Contact: Zimmer Pte Ltd
Contact No./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
|
HSA 6004101-008-18-11_51 FSN_Redacted568 KB
|
|
23 July 2018
|
RAPIDPoint® 405/500 Systems and RAPIDLab® 1245/1265 Systems, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-005/18/16_69)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
|
HSA 6004101-022-18-16_69 FSN99 KB
|
|
20 July 2018
|
IH-COM FULLVERSION AND IH-COM FOR READER, DiaMed GmbH (HSA 600:41/01-005/18/09_67)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact No./Email: 6490 4262
|
HSA 6004101-027-18-09_67 FSN_Redacted2790 KB
|
|
20 July 2018
|
Architect Creatinine Kinase, Abbott GmbH & Co. KG (HSA 600:41/01-005/18/09_61)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com
|
HSA 6004101-005-18-09_61 FSN_Redacted320 KB
|
|
19 July 2018
|
STA - Néoplastine CI 10 and STA - Néoplastine CI Plus 10, Diagnostica Stago (HSA 600:41/01-137/18/01_59)
Local Contact: All Eights (Singapore) Ptd Ltd
Contact No./Email: 6288 6388 / alleight@alleight.com
|
HSA 6004101-137-18-01_59 FSN42 KB
|
|
19 July 2018
|
ARCHITECT c4000 Processing Module (02P24), ARCHITECT c8000 Processing Module (01G06), ARCHITECT c16000 Processing Module (03L77), Abbott Laboratories (HSA 600:41/01-005/18/08_34)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com
|
HSA 6004101-005-18-08_34 FSN370 KB
|
|
18 July 2018
|
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
|
HSA 6004101-026-18-21_54 FSN_Redacted357 KB
|
|
18 July 2018
|
VITROS Chemistry Products Cl-Slides and CREA Slides, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/18/09_31)
Local Contact: ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD
Contact No./Email: 6486 1151
|
HSA 6004101-303-18-09_31_FSN_Redacted25344 KB
|
|
17 July 2018
|
da Vinci Si, Xi and X Surgeon Consoles and da Vinci Si Patient Side Carts, Intuitive Surgical, Inc. (HSA 600:41/01-070/18/13_52)
Local Contact: Transmedic Pte Ltd
Contact No./Email: 6477 6101 / regional.pms@transmedicgroup.com
|
HSA 6004101-070-18-13_52 FSN_Redacted1392 KB
|
|
17 July 2018
|
EZ1 Advanced XL instrument, QIAGEN GmbH (HSA 600:41/01-179/18/01_49)
Local Contact: QIAGEN Singapore Pte. Ltd.
Contact No./Email: 6854 8100
|
HSA 6004101-179-18-01_49 FSN_Redacted255 KB
|
|
17 July 2018
|
Ortho VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2; Ortho-Clinical ECI Immunodiagnostics Products PSA Reagent Pack/Calibrator; Ortho VITROS Immunodiagnostic Products FSH Reagent Pack; Ortho VITROS Immunodiagnostic Products Prolactin Reagent Pack; Ortho-Clinical VITROS Immunodiagnostic Products TSH Reagent Pack, Ortho Clinical Diagnostics (HSA 600:41/01-303/18/08_75)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte. Ltd.
Contact No./Email: 6486 1151
|
HSA 6004101-303-18-08_75 FSN (revised)_Redacted6645 KB
|
|
17 July 2018
|
CFX96 Optical Reaction Modules, Life Science Group. Bio-Rad Laboratories, Inc. (HSA 600:41/01-027/18/08_73)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact No./Email: 6490 4262
|
HSA 6004101-027-18-08_73 FSN_Redacted468 KB
|
|
16 July 2018
|
Teleflex LMA Unique™, Teleflex Medical (HSA 600:41/01-139/18/03_63)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact No./Email: 6439 3046
|
HSA 6004101-139-18-03_63_FSN_Redacted591 KB
|
|
16 July 2018
|
PEG Fully Threaded, Locking 2.5mm x 10mm, Biomet Orthopaedics (HSA 600:41/01-008/18/10_64)
Local Contact: Zimmer Pte Ltd
Contact No./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
|
HSA 6004101-008-18-10_64_FSN_Redacted386 KB
|
|
12 July 2018
|
Thermo Scientific™ Remel™ Agglutinating Sera Shigella boydii Polyvalent 2 (7 to 11), Remel Europe Ltd (Thermo Fisher Scientific)(HSA 600:41/01-178/18/05_70)
Local Contact: Thermo Scientific Microbioology Pte Ltd
Contact No./Email: 6362 9390
|
HSA 6004101-178-18-05_70 FSN_Redacted253 KB
|
|
11 July 2018
|
Perifix Catheter Connectors, B.Braun Melsungen AG(HSA 600:41/01-012/18/05_51)
Local Contact: B. Braun Singapore Pte Ltd
Contact No./Email: 6213 0933 / press.sg@bbraun.com
|
HSA 6004101-012-18-05_51 FSN_Redacted1776 KB
|
|
11 July 2018
|
JELONET 15CM X 2M CTN 12 (JOAR), Smith & Nephew Medical Limited (HSA 600:41/01-073/18/16_35)
Local Contact: Smith & Nephew Pte. Ltd.
Contact No./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com
|
HSA 6004101-073-18-16_35 FSN55 KB
|
|
9 July 2018
|
Alinity s System, Abbott GmbH & Co. Kg (HSA 600:41/01-005/18/07_67)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact No./Email: 6914 8000 / FSN@enquiry@abbott.com
|
HSA 6004101-005-18-07_67 FSN102 KB
|
|
6 July 2018
|
Sorin Group Italia Perceval S Sutureless Heart Valve, Sorin Group Italia S.r.l. (HSA 600:41/01-299/18/01_50)
Local Contact: LivaNova Singapore Pte Ltd
Contact No./Email: 6293 1033
|
HSA 6004101-299-18-01_50 FSN_Redacted1071 KB
|
|
5July 2018
|
MAYFIELD® Infinity XR2 Radiolucent Base Unit (A2079), Standard; MAYFIELD® Infinity XR2 Low Profile Base Unit (A2079A); MAYFIELD® Infinity XR2 Radiolucent Base Unit, Extended (A2079E) and MAYFIELD® Spine Table Adaptor (A2600R), Integra LifeSciences Corporation (HSA 600:41/01-070/18/12_44)
Local Contact: Transmedic Pte Ltd
Contact No./Email: 6477 6101 / regional.pms@transmedicgroup.com
|
HSA 6004101-070-18-12_44 FSN_Redacted1392 KB
|
|
4 July 2018
|
Atellica Solution System Software V1.13 and Lower, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/18/15_67)
Local Contact: Siemens Healthcare Pte. Ltd.
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com
|
HSA 6004101-022-18-15_67 FSN133 KB
|
|
3 July 2018
|
Guardian™ Connect Mobile App, Medtronic MiniMed (HSA 600:41/01-009/18/11_35)
Local Contact: Medtronic International Ltd.
Contact No./Email: 6439 5000
|
HSA 6004101-009-18-11_35 FSN_Redacted842 KB
|
|
3 July 2018
|
Alinity hq Analyzer, Abbott (HSA 600:41/01-005/18/06_59)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com
|
HSA 6004101-005-18-06_59 FSN_Redacted112 KB
|
|
3 July 2018
|
GE Healthcare MRI system: 1.5T Signa HDx, 3.0T Signa HDx, GE Medical Systems LLC (HSA 600:41/01-010/18/16_18)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
|
HSA 6004101-010-18-16_18 FSN_Redacted603 KB
|
|
3 July 2018
|
ARIES hand held Barcode Scanner, Luminex Corporation (HSA 600:41/01-148/18/01_61)
Local Contact: DKSH Singapore Pte Ltd
Contact No./Email: 6471 1466 / hec-ra.sin@dksh.com
|
HSA 6004101-148-18-01_61 FSN_Redacted183 KB
|
|
3 July 2018
|
Ring Transjugular Intrahepatic Access Set, Cook Incorporated (HSA 600:41/01-013/18/06_37)
Local Contact: Cook South East Asia Pte LtdContact No./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com
|
HSA 6004101-013-18-06_37 FSN_Redacted110 KB
|
|
3 July 2018
|
Chorion Villus Sampling Needle Sets, William A. Cook Australia Pty. Ltd (HSA 600:41/01-013/18/05_38)
Local Contact: Cook South East Asia Pte LtdContact No./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com
|
HSA 6004101-013-18-05_38 FSN_Redacted1060 KB
|
|
3 July 2018
|
CADD®-Solis VIP Infusion Pumps, Smiths Medical ASD, Inc. (HSA 600:41/01-017/18/03_52)
Local Contact: IDS Medical Systems (Singapore) Pte Ltd
Contact No./Email: 6690 7330
|
HSA 6004101-017-18-03_52 FSN_Redacted874 KB
|
|
2 July 2018
|
BACT/ALERT® VIRTUO® A, B, & A Unit China, BioMerieux Inc (HSA 600:41/01-146/18/05_34)
Local Contact: Biomerieux Singapore Pte Ltd
Contact No./Email: 6801 6706
|
HSA 6004101-146-18-05_34 FSN_Redacted266 KB
|
|
2 July 2018
|
Proteus 235 – Proton Therapy System , Ion Beam Applications S.A. (HSA 600:41/01-070/18/11_56)
Local Contact: Transmedic Pte LtdContact No./Email: 6447 6101 / regulatory@transmedicgroup.com
|
HSA 6004101-070-18-11_56 FSN_Redacted940 KB
|
|
2 July 2018
|
M350 OHX, M525 F50 and M525 F40 Microscope Systems, Leica Microsystems (Schweiz) AG(HSA 600:41/01-126/18/03_66)
Local Contact: Leica Instruments (Singapore) Pte Ltd
Contact No./Email: 6569 1828
|
HSA 6004101-126-18-03_66 FSN_Redacted2834 KB
|
|
2 July 2018
|
Wingspan Stent System, Stryker Neurovascular (HSA 600:41/01-070/18/10_45)
Local Contact: Transmedic Pte LtdContact No./Email: 6447 6101 / regulatory@transmedicgroup.com
|
HSA 6004101-070-18-10_45 FSN71 KB
|
|
2 July 2018
|
Fujifilm 500 Series Duodenoscopes, Fujifilm Corporation (HSA 600:41/01-173/18/01_54)
Local Contact: Fujifilm Asia Pacific Pte Ltd
Contact No./Email: 6380 9933
|
HSA 6004101-173-18-01_54 FSN_Redacted1237 KB
|
|
6 June 2018
|
CORAIL® AMT Neck Trials Surgical Instruments, Depuy (Ireland) (HSA 600:41/01-002/18/06_38)
Local Contact: Johnson & Johnson Pte Ltd
Contact No./Email: 6918 8304
|
HSA 6004101-002-18-06_38 FSN (v2)_Redacted1462 KB
This FSN is an update to the original FSN published in June 2018.
|
|
30 Apr 2018
|
MagNA Pure 24 System, Roche Diagnostics GmbH (HSA 600:41/01-016/18/05_67)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com
|
HSA 6004101-016-18-05_67 FSN_ Update339 KB
This FSN is an update to the original FSN published in Apr 2018.
|
|
21 Dec 2017
|
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
|
HSA 6004101-016-17-20_38 FSNv5423 KB
This FSN is an update to the original FSN published in Dec 2017.
|
|
24 Nov 2016
|
IMMULITE/ IMMULITE 1000 PSA / IMMULITE 2000/ IMMULITE 2000 XPi PSA, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/16/53_24)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg@siemens.com
|
HSA 6004101-022-16-53_24 FSN93 KB
This updated FSN replaces the original FSN published in Nov 2016.
|