|
Date of Notification
|
Title
|
FSN
|
| 30 Aug 2019 |
Philips S7-3t & S8-3t Transesophageal (TEE) Transducers, Philips Ultrasound, Inc (HSA 600:41/01-026/19/27_86)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact no./Email: 1800 744 5477
|
HSA 6004101-026-19-27_86 FSN165 KB |
|
29 Aug 2019
|
Alaris™ EtCOz Module (Model 8300), CareFusion 303 Inc (HSA 600:41/01-003/19/11_46)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 6664 2784 / Customercomplaint@bd.com
|
HSA 6004101-003-19-11_46 FSN2776 KB |
|
29 Aug 2019
|
8 G x 10 CM JamshidiTM Crown Bone Marrow Biopsy/Aspiration Needle with MAC, CareFusion (HSA 600:41/01-003/19/12_18)
Local Contact: Becton Dickinson Holdings Pte Ltd (BD)
Contact no./Email: 6664 2784 / Customercomplaint@bd.com
|
HSA 6004101-003-19-12_18 FSN186 KB |
|
28 Aug 2019
|
Beckman Coulter Enzymatic Creatinine; Triglycerides; Uric Acid; Direct Bilirubin; Total Bilirubin, Beckman Coulter (HSA 600:41/01-052/19/04_78)
Local Contact: Beckman Coulter Singapore
Contact no./Email: 6340 7126
|
HSA 6004101-052-19-04_78 FSN76 KB |
| 28 Aug 2019 |
Ultrasonic Diagnostic Apparatus WS80A and HS70SA, Samsung Medison Co., Ltd (HSA 600:41/01-346/19/01_80)
Local Contact: Quest Asia Technologies Pte Ltd
Contact no./Email: 6746 2628 / CS@QuestAsia.sg |
HSA 6004101-346-19-01_80 FSN337 KB |
|
28 Aug 2019
|
Coopersurgical Transwarmer Warming Infant Transport Mattress, Coopersurgical Inc (HSA 600:41/01-063/19/04_50)
Local Contact: Draeger Singapore Pte Ltd
Contact no./Email: 6872 9288 / draeger.sg@draeger.com
|
HSA 6004101-063-19-04_50 FSN790 KB |
|
27 Aug 2019
|
Lyphocheck Specialty Immunoassay Control, Bio-Rad Laboratories Inc (HSA 600:41/01-027/19/06_73)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
|
HSA 6004101-027-19-06_73 FSN130 KB |
| 26 Aug 2019 |
Principelle IF Honey Based Lonogen Formulation Ointment, Principelle BV (HSA 600:41/01-343/19/01_46)
Local Contact: Recura Pte Ltd
|
HSA 6004101-343-19-01_46 FSN1391 KB |
|
26 Aug 2019
|
CHOC II AGAR and COLUMBIA CNA WITH SHEEP BLOOD AGAR/ CHOC II, Thermo Scientific Microbiology Sdn. Bhd. (HSA 600:41/01-178/19/04_31)
Local Contact: THERMO SCIENTIFIC MICROBIOLOGY PTE LTD
Contact no./Email: 6499 9999 / cs.mbd.sg@thermofisher.com
|
HSA 6004101-178-19-04_31 FSN1289 KB |
|
26 Aug 2019
|
LivaNova Stockert SCP Centrifugal Pump System, LivaNova Deutschland GmbH (HSA 600:41/01-299/19/02_50)
Local Contact: LivaNova Singapore Pte Ltd
Contact no./Email: 6293 1033
|
HSA 6004101-299-19-02_50 FSN841 KB |
|
26 Aug 2019
|
NobelParallel CC NP 3.75x10mm, Nobel Biocare AB (HSA 600:41/01-168/19/04_87)
Local Contact: Kavo Dental Supply
Contact no./Email: 6311 9812
|
HSA 6004101-168-19-04_87 FSN83 KB |
|
23 Aug 2019
|
CentriMag Motor, Thoratec Switzerland GmbH (HSA 600:41/01-339/19/04_63)
Local Contact: Abbott Medical (Singapore) Pte Ltd
Contact no./Email: 6914 8000
|
HSA 6004101-339-19-04_63 FSN74 KB |
|
23 Aug 2019
|
ThermoScientificTM OxoidTM Meropenem 32 M.I.C.E. strip, Oxoid Limited (HSA 600:41/01-178/19/05_75)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6499 9999 / cs.mbd.sg@thermofisher.com
|
HSA 6004101-178-19-05_75 FSN400 KB |
|
22 Aug 2019
|
EMBLEM™ S-ICDS, EMBLEM MRI S-ICDS, Boston Scientific Corporation (HSA 600:41/01-007/19/07_44)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com
|
HSA 6004101-007-19-07_44 FSN364 KB |
|
22 Aug 2019
|
Atellica UAS 800 Analyzer and Atellica 1500 Automated Urinalysis System, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/22_70)
Local Contact: Siemens Healthcare Pte. Ltd.
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
|
HSA 6004101-022-19-22_70 FSN112 KB |
|
21 Aug 2019
|
Mobi-C Implant, LDR Medical (HSA 600:41/01-008/19/06_85)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
|
HSA 6004101-008-19-06_85 FSN257 KB |
|
21 Aug 2019
|
Triathlon Femoral Distal Augment, Howmedica Osteonics Corporation (HSA 600:41/01‐014/19/03_86)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: 6662 5930
|
HSA 6004101-014-19-03_86 FSN132 KB |
|
19 Aug 2019
|
Palacos LV+G, Palacos MV+G, Palacos R+G, Heraeus Medical GmbH (HSA 600:41/01-344/19/01_64)
Local Contact: Indola Pharma Link Singapore Pte Ltd
Contact no./Email: 6636 9007 / indola@singnet.com.sg
|
HSA 6004101-344-19-01_64 FSN6377 KB |
|
19 Aug 2019
|
Blanketrol III Hyper-hypothermia System, Gentherm Medical LLC (HSA 600:41/01-021/19/03_76)
Local Contact: Thermal International (S) Pte Ltd
Contact no./Email: 6225 2911 / sales@thermal.com.sg
|
HSA 6004101-021-19-03_76 FSN5703 KB |
|
16 Aug 2019
|
Atellica CH 930 Analyzer, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/20_67)
Local Contact: Siemens Healthcare Pte. Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
|
HSA 6004101-022-19-20_67 FSN300 KB |
|
16 Aug 2019
|
Siemens ATELLICA® IM 1300 ANALYZER, ATELLICA® IM 1600 ANALYZER, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/21_57)
Local Contact: Siemens Healthcare Pte. Ltd.
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
|
HSA 6004101-022-19-21_57 FSN128 KB |
|
16 Aug 2019
|
Tina-quant Soluble Transferrin Receptor (sTFR) assay, Roche Diagnostics GmbH (HSA 600:41/01-016/19/18_59)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
|
HSA 6004101-016-19-18_59 FSN416 KB |
|
16 Aug 2019
|
Ru-106 Eye Applicator CCB, Eckert & Ziegler BEBIG GmbH (HSA 600:41/01-070/19/06_71)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6737 1945 / regional.pms@transmedicgroup.com
|
HSA 6004101-070-19-06_71 FSN1299 KB |
| 15 Aug 2019 |
Monnal T40, T50, T60, T75, Air Liquide Medical Systems S.A. (HSA 600:41/01-338/19/03_35)
Local Contact: Nyprax Pharma Pte Ltd
Contact no./Email: 6348 0481 / nypraxreg@singnet.com.sg
|
HSA 6004101-338-19-03_35 FSN166 KB |
| 15 Aug 2019 |
Rocket KCH Fetal Bladder Drain, Rocket Medical PLC (HSA 600:41/01-287/19/01_79)
Local Contact: Progress Healthcare Pte Ltd
Contact no./Email: 6297 5955 / sales@progress.com.sg
|
HSA 6004101-287_19_01_79 FSN232 KB |
|
15 Aug 2019
|
TRILLY PED.AF FULL COATED STE (EU6582 CONVENIENCE KIT TRILLY), Eurosets S.R.L (HSA 600:41/01-218/19/01_80)
Local Contact: Perfusion Services & Supplies Pte Ltd
Contact no./Email: 6398 0630 / admin@perfusionsvcs.com
|
HSA 6004101-218-19-01_80 FSN351 KB |
|
15 Aug 2019
|
Concerto / Basic Shower Trolley, ArjoHuntleigh AB (HSA 600:41/01-065/19/02_66)
Local Contact: Arjo South East Asia Pte. Ltd.
Contact no./Email: 6202 7366 / singapore@arjo.com
|
HSA 6004101-065-19-02_66 FSN353 KB |
| 14 Aug 2019 |
EASYRET, Quantel Medical (HSA 600:41/01-261/19/02_74)
Local Contact: Swissmed Pte Ltd
Contact no./Email: 6635 6080 / info@swissmed.asia
|
HSA 6004101-261-19-02_74 FSN150 KB |
|
14 Aug 2019
|
Atellica IM anti-CCP IgG (aCCP) Assay, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/19/19_78)
Local Contact: Siemens Healthcare Pte. Ltd.
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
|
HSA 6004101-022-19-19_78 FSN113 KB |
|
14 Aug 2019
|
Boston Scientific ZOOM Latitude Programming System, Boston Scientific Corporation (HSA 600:41/01-007/19/06_64)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_ Query@bsci.com
|
HSA 6004101-007-19-06_64 FSN229 KB |
|
14 Aug 2019
|
Philips Efficia DFM 100, Philips Goldway (Shenzhen) Industrial Inc. (HSA 600:41/01-026/19/26_48)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact no./Email: 1800 744 5477
|
HSA 6004101-026-19-26_48 FSN2860 KB |
|
13 Aug 2019
|
Titanium Abutments, Nobel Biocare AB (HSA 600:41/01-168/19/03_52)
Local Contact: Kavo Dental Supply
Contact no./Email: 6311 9842
|
HSA 6004101-168-19-03_52 FSN51 KB |
|
13 Aug 2019
|
Proteus XR/a Fixed RAD systems, GE Hualan Medical Systems Co. Ltd. (HSA 600:41/01-010/19/22_63)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
|
HSA 6004101-010-19-22_63 FSN96 KB |
|
08 Aug 2019
|
Hemospray Endoscopic Hemostat, Wilson-Cook Medical, Inc. (HSA 600:41/01-013/19/09_62)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com
|
HSA 6004101-013-19-09_62 FSN564 KB |
|
08 Aug 2019
|
AssayTip/AssayCup tray, Roche Diagnostics GmbH (HSA 600:41/01-016/19/17_69)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
|
HSA 6004101-016-19-17_69 FSN494 KB |
| 07 Aug 2019 |
ClosureRFG™ Radiofrequency Generator RFG3, Medtronic, Inc (HSA 600:41/01-046/19/09_43)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6489 6849
|
HSA 6004101-046-19-09_43 FSN2099 KB |
|
07 Aug 2019
|
Blanketrol II hyper-hypothermia system (230V), Gentherm Medical LLC (HSA 600:41/01-021/19/02_52)
Local Contact: Thermal International (S) Pte Ltd
Contact no./Email: 6225 2911 / sales@thermal.com.sg
|
HSA 6004101-021-19-02_52 FSN4788 KB |
|
06 Aug 2019
|
Edwards Lifesciences TruWave Disposable Pressure Transducer, Edwards Lifesciences LLC (HSA 600:41/01-060/19/05_48)
Local Contact: Edwards Lifesciences (Asia) Pte Ltd
Contact no./Email: 68836836
|
HSA 6004101-060-19-05_48 FSN178 KB |
| 06 Aug 2019 |
Medtronic Micra™ Delivery System, Medtronic Inc (HSA 600:41/01-009/19/11_56)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5077
|
HSA 6004101-009-19-11_56 FSN193 KB |
|
06 Aug 2019
|
Ortho-Clinical Biovue® System ABD Confirmation Cassette, Ortho-Clinical Diagnostics (HSA 600:41/01-303/19/06_75)
Local Contact: ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD
Contact no./Email: 6486 1151
|
HSA 6004101-303-19-06_75 FSN150 KB |
|
05 Aug 2019
|
Air Liquide Monnal T60, Air Liquide Medical Systems S.A. (HSA 600:41/01-338/19/02_76)
Local Contact: Nyprax Pharma Pte Ltd
Contact no./Email: 6348 0481 / nypraxreg@singnet.com.sg
|
HSA 6004101-338-19-02_76 FSN116 KB |
| 02 Aug 2019 |
Norm-O-Temp hyperthermia system, Gentherm Medical LLC (HSA 600:41/01-021/19/01_51)
Local Contact: Thermal International (S) Pte Ltd
Contact no./Email: 6225 2911 / sales@thermal.com.sg |
HSA 6004101-021-19-01_51 FSN2373 KB |
|
01 Aug 2019
|
ONLINE TDM Vancomycin Gen. 3, Roche Diagnostics GmbH (HSA 600:41/01-016/19/16_34)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
|
HSA 6004101-016-19-16_34 FSN143 KB |
|
01 Aug 2019
|
DYONICS 4.5 mm Full Radius Curved Concave Blade, Smith & Nephew Inc (HSA 600:41/01-073/19/09_51)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com
|
HSA 6004101-073-19-09_51 FSN82 KB |