|
Date of Notification
|
Title
|
FSN
|
| 31 May 2019 |
ARCHITECT BNP Calibrators/Controls, Abbott GmbH and Co KG (HSA 600:41/01-005/19/22_75)
Local Contact: Abbott Laboratories (Singapore ) Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com |
HSA 6004101-005-19-22_75 FSN387 KB |
| 30 May 2019 |
Abbott Hemoglobin A1c Calibrators, Abbott Laboratories (HSA 600:41/01-005/19/21_57)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com |
HSA 6004101-005-19-21_57_FSN290 KB |
| 30 May 2019 |
Healing Abutment Conical Connection RP Ǿ3.6 x 5 mm, Nobel Biocare AB (HSA 600:41/01-168/19/01_71)
Local Contact: Nobel Biocare AB
Contact No./Email: 6311 9842 |
HSA 6004101-168-19-01_71 FSN57 KB |
| 29 May 2019 |
Sheridan® Endotracheal Tubes and Connectors, Teleflex Medical (HSA 600:41/01-139/19/02_18)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact No./Email: 6439 3046 |
HSA 6004101-139-19-02_18 FSN152 KB |
| 29 May 2019 |
Senographe Pristina with Serena, GE Medical Systems SCS (HSA 600:41/01-010/19/15_56)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com |
HSA 6004101-010-19-15_56 FSN274 KB |
| 29 May 2019 |
DVR® Crosslock ePAK™ Screw Driver, DVR® Crosslock ePAK™ Depth Gauge, K-Wire Trochar Tip, Biomet Trauma (HSA 600:41/01-008/19/03_79)
Local Contact: Zimmer Pte Ltd
Contact No./Email: 6854 7222 / cs.singapore@zimmerbiomet.com |
HSA 6004101-008-19-03_79 FSN263 KB |
| 28 May 2019 |
Tina‑quant IgA Gen.2 on cobas c 701/702, Roche Diagnostics GmbH (HSA 600:41/01-016/19/09_73)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com |
HSA 6004101-016-19-09_73 FSN36 KB |
| 28 May 2019 |
AssayTip/ AssayCup, Roche Diagnostics GmbH (HSA 600:41/01-016/19/08_34)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com |
HSA 6004101-016-19-08_34 FSN152 KB |
| 27 May 2019 |
ARTIS zee and AXIOM Artis systems with Generator A100, Siemens Healthcare GmbH (HSA 600:41/01-022/19/11_46)
Local Contact: Siemens Healthcare Pte Ltd
Contact No./Email: ui-handling.sg.dl@siemens-healthineers.com |
HSA 6004101-022-19-11_46 FSN771 KB |
| 27 May 2019 |
Incisive Computed Tomography X-ray System, Philips Healthcare (Suzhou) Co. Ltd. (HSA 600:41/01-026/19/16_74)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact No./Email: 1800 744 547 |
HSA 6004101-026_19-16_74_FSN1343 KB |
| 27 May 2019 |
Lactate Gen.2 (Cobas Integra 400 Plus), Roche Diagnostics GmbH (HSA 600:41/01-016/19/07_67)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com |
HSA 6004101-016-19-07_67 FSN377 KB |
| 27 May 2019 |
HeartStart MRx Defibrillator/ Monitor, Philips Medical Systems (HSA 600:41/01-026/19/15_68)
Local Contact: Philips Electronics (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477 |
HSA 6004101-026-19-15_68 FSN449 KB |
| 27 May 2019 |
Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter, Cook Incorporated (HSA 600:41/01-013/19/07_68)
Local Contact: Cook South East Asia Pte Ltd
Contact No./Email: 6812 7400 / SNG_RegulatoryAffairs@CookMedical.com |
HSA 6004101-013-19-07_68 FSN74 KB |
| 27 May 2019 |
iQ Control/Focus Set, Iris Diagnostics (HSA 600:41/01-052/19/03_70)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact No./Email: 6340 7126 |
HSA 6004101-052-19-03_70 FSN229 KB |
| 24 May 2019 |
Alinity c Complement C3 Reagent Kit, Alinity c Immunoglobulin A Reagent Kit, Alinity c Immunoglobulin G Reagent Kit, Alinity c Immunoglobulin M Reagent Kit, Alinity c Apolipoprotein A1 Reagent Kit, Alinity c Complement C4 Reagent Kit, Alinity c Haptoglobin Reagent Kit, Alinity c Apolipoprotein B Reagent Kit, Alnity c Transferrin Reagent Kit, Abbott GmbH & Co KG (HSA 600:41/01-005/19/20_57)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com |
HSA 6004101-005-19-20_57 FSN241 KB |
| 24 May 2019 |
Coloplast Biatain Ibu Non-Adhesive Foam Dressing & Coloplast Biatain Ag Foam Dressing, Coloplast A/S (HSA 600:41/01-341/19/01_18)
Local Contact: Coloplast A/S Singapore Branch |
HSA 6004101-341-19-01_18 FSN402 KB |
| 24 May 2019 |
Covidien Endo GIA™ articulating reloads with Tri-Staple™ technology, Covidien llc (HSA 600:41/01-046/19/07_52)
Local Contact: Covidien Pte Ltd
Contact No./Email: 6439 6974 |
HSA 6004101-046-19-07_52 FSN342 KB |
| 24 May 2019 |
ARCHITECT Complement C3, ARCHITECT Immunoglobulin A, ARCHITECT Immunoglobulin G, ARCHITECT Immunoglobulin M, ARCHITECT Apolipoprotein A1, ARCHITECT Complement C4, ARCHITECT Haptoglobin, ARCHITECT Apolipoprotein B, ARCHITECT Transferrin, Abbott Laboratories (HSA 600:41/01-005/19/19_23)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com |
HSA 6004101-005-19-19_23 FSN318 KB |
|
24 May 2019
|
Alinity ci-series System Control Module, Abbott GmbH & Co KG (HSA 600:41/01-005/19/18_59)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com
|
HSA 6004101-005-19-18_59 FSN384 KB
|
23 May 2019
|
ID-DIACELL I-II-III ASIA, Diamed GmbH (HSA 600:41/01-027/19/03_67)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact No./Email: 6490 4262
|
HSA 6004101-027-19-03_67 FSN1781 KB |
23 May 2019
|
Prismaflex System, Prismaflex 4.11, Prismaflex 6.10 ROW and Prismaflex 8.XX ROW (8.10 software), Gambro Lundia AB (HSA 600:41/01-001/19/02_56)
Local Contact: Baxter Healthcare (Asia) Pte Ltd
Contact No./Email: 6826 2616
|
HSA 6004101-001-19-02_56 FSN2797 KB |
| 22 May 2019 |
O-arm™ 1000 Imaging System, Medtronic Inc (HSA 600:41/01‐009/19/08_86)
Local Contact: Medtronic International Ltd.
Contact No./Email: 6439 5000
|
HSA 6004101‐009-09-08_86 FSN919 KB |
| 22 May 2019 |
Medtronic Guardian™ Connect CGM System, Medtronic MiniMed (HSA 600:41/01-009/19/09_51)
Local Contact: Medtronic International Ltd.
Contact No./Email: 6439 5000
|
HSA 6004101-009-19-09_51 FSN494 KB |
|
22 May 2019
|
ETHIBOND EXCEL Polyester Nonabsorbable Surgical Suture, Ethicon LLC and Ethicon, Inc. (HSA 600:41/01-002/19/14_46)
Local Contact: Johnson & Johnson Pte Ltd
Contact No./Email: 6918 6717
|
HSA 6004101-002-19-14_46 FSN_Redacted246 KB
|
|
21 May 2019
|
Discovery PET/CT 610, 710; Optima PET/CT 560, 560FX; Discovery IQ; Discovery MI, MI DR; GE Medical Systems, LLC (HSA 600:41/01-010/19/14_80)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
|
HSA 6004101-010-19-14_80 FSN_Redacted98 KB
|
|
21 May 2019
|
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only), 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0), Mako Surgical Corp (HSA 600:41/01-070/19/05_50)
Local Contact: Transmedic Pte Ltd
Contact No./Email: 6662 5930 / Asean.pms@stryker.com
|
HSA 6004101-070-19-05_50 FSN146 KB
|
|
17 May 2019
|
QUADROX-i Neonatal, Maquet Cardiopulmonary GmbH (HSA 600:41/01-224/19/05_86)
Local Contact: Getinge South East Asia Pte Ltd
Contact No./Email: 6296 1992
|
HSA 6004101-224-19-05_86 FSN_Redacted332 KB
|
|
16 May 2019
|
WEINMANN Emergency Medical Technology MEDUCORE Standard Monitor/Defibrillator, WEINMANN Emergency Medical Technology GmBh + Co.KG (HSA 600:41/01-056/19/03_80)
Local Contact: Gold Lite Pte Ltd
Contact No./Email: 6273 0487
|
HSA 6004101-056-19-03_80 FSN180 KB
|
|
16 May 2019
|
CELL-DYN Emerald and Emerald Diluent Tubing, Abbott Laboratories (HSA 600:41/01-005/19/17_23)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000 / FSN_enquiry@abbott.com
|
HSA 6004101-005-19-17_23 FSN_Redacted290 KB
|
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15 May 2019
|
Vscan Extend, GE Vingmed Ultrasound AS (HSA 600:41/01-010/19/13_52)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
|
HSA 6004101-010-19-13_52 FSN_Redacted158 KB
|
|
15 May 2019
|
Cook Neff Percutaneous Access Sets, Cook Incorporated (HSA 600:41/01-013/19/06_64)
Local Contact: Cook South East Asia Pte Ltd
Contact No./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com
|
HSA 6004101-013-19-06_64 FSN_Redacted72 KB
|
|
15 May 2019
|
Cook Zenith Alpha Abdominal Endovascular Graft, William Cook Europe Aps(HSA 600:41/01-013/19/05_62)Local Contact: Cook South East Asia Pte Ltd
Contact No./Email: 6812 7400 / SNG-RegulatoryAffairs@CookMedical.com
|
HSA 6004101-013-19-05_62 FSN_Redacted1423 KB
|
|
15 May 2019
|
Renasys-F Foam Dressing Kit, Smith & Nephew Medical Ltd (HSA 600:41/01-073/19/08_48)
Local Contact: Smith & Nephew Pte Ltd
Contact No./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com
|
HSA 6004101-073-19-08_48 FSN100 KB
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|
14 May 2019
|
Feeding Tubes, Nelaton Catheters, Levin Tubes, Rectal Catheter, Ryles Tube, Suction Catheters, Stomach Tubes, Medical Packs, Pennine Healthcare (HSA 600:41/01-044/19/02_50)
Local Contact: Optimal Medical Products Pte Ltd
Contact No./Email: 6253 5247 / sales@optimalmedical.com.sg
|
HSA 6004101-044-19-02_50 FSN_Redacted489 KB
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|
13 May 2019
|
Covidien Emprint Ablation Pumps, Remote Temperature Probes, Reusable Cables and Generators, Covidien llc (HSA 600:41/01-046/19/06_76)
Local Contact: Covidien Pte Ltd
Contact No./Email: 6439 6974
|
HSA 6004101-046-19-06_76 FSN_Redacted1024 KB
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|
13 May 2019
|
D-Special Product Codes of PROLENE® Polypropylene Non-Absorbable Suture and PRONOVA® Poly (Hexafluoropropylene - VDF) Suture, Ethicon LLC and Ethicon, Inc. (HSA 600:41/01-002/19/13_44)
Local Contact: Johnson & Johnson Pte Ltd
Contact No./Email: 6918 6717
|
HSA 6004101-002-19-13_44 FSN_Redacted205 KB
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10 May 2019
|
Medtronic HeartWare™ Monitor AC Adapter, HeartWare (HSA 600:41/01-263/19/02_63)
Local Contact: Emergo Consulting Pte Ltd
Contact No./Email: 6854 7976 / SEAsiaVigilance@ul.com
|
HSA 6004101-263-19-02_63 FSN_Redacted255 KB
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9 May 2019
|
ARCHITECT c Systems Mixer, Abbott Laboratories (HSA 600:41/01-005/19/16_61)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact No./Email: 6914 8000
|
HSA 6004101-005-19-16_61 FSN476 KB
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8 May 2019
|
Membrane Changerand their Inserts of Sentec Digital Monitoring System, SenTec Ag (HSA 600:41/01-199/19/03_43)
Local Contact: Junnimed Services Pte Ltd
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HSA 6004101-199-19-03_43 FSN_Redacted210 KB
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8 May 2019
|
VICRYL™ Plus Absorbable Surgical Suture, and ETHIBOND Excel Polyester Suture, Ethicon LLC (HSA 600:41/01-002/19/12_51)
Local Contact: Johnson & Johnson Pte Ltd
Contact No./Email: 6918 6717
|
HSA 6004101-002-19-12_51 FSN_Redacted283 KB
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8 May 2019
|
CORAIL® Cementless Stem, DePuy (Ireland) (HSA 600:41/01-002/19/11_54)
Local Contact: Johnson & Johnson Pte Ltd
Contact No./Email: 6918 6717
|
HSA 6004101-002-19-11_54 FSN_Redacted184 KB
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7 May 2019
|
BILT3 COBAS C 111, BILT3 COBAS INTEGRA® 400 PLUS, Roche Diagnostics GmbH (HSA 600:41/01-016/19/06_78)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact No./Email: sg.regulatory@roche.com
|
HSA 6004101-016-19-06_78 FSN401 KB
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7 May 2019
|
Medtronic Azure™ MRI SureScan™ Pacemaker, Medtronic Astra™ MRI SureScan™ Pacemaker, Medtronic Percepta™ CRT-P MRI SureScan™, Medtronic Serena™ CRT-P MRI SureScan™, Medtronic Solara™ CRT-P MRI SureScan™, Medtronic Inc (HSA 600:41/01-009/19/07_71)
Local Contact: Medtronic International Limited
Contact No./Email: 6436 5077
|
HSA 6004101-009-19-07_71 FSN_Redacted134 KB
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6 May 2019
|
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS) Flowmeter, Terumo Cardiovascular Systems Corporation (HSA 600:41/01-028/19/03_79)
Local Contact: Terumo Singapore Pte Ltd
Contact No./Email: 6291 3603
|
HSA 6004101-028-19-03_79 FSN_Redacted3058 KB
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6 May 2019
|
Access Free T3, Access Total T3, Access Free T4, Access GI Monitor (GI Mon), Access Thyroglobulin (Tg), Access Thyroglobulin Antibody II (TgAbII), Beckman Coulter Inc (HSA 600:41/01-052/19/02_73)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact No./Email: 6340 7126
|
HSA 6004101-052-19-02_73 FSN_Redacted118 KB
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6 May 2019
|
Prestige II, Prestige VH, Prestige SI, Prestilix 1600X, Precision 500D, Flexmed, PROTEUS XR/A and SILHOUETTE VR, GE Hualun Medical Systems Co Ltd (HSA 600:41/01-010/19/12_35)
Local Contact: GE Healthcare Pte Ltd
Contact No./Email: 6277 7668 / svc@ge.com
|
HSA 6004101-010-19-12_35 FSN_Redacted180 KB
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6 May 2019
|
6F Sherpa NX Active Catheters, Medtronic Inc (HSA 600:41/01-009/19/06_66)
Local Contact: Medtronic International Limited
Contact No./Email: 6436 5077
|
HSA 6004101-009-19-06_66 FSN481 KB
|
|
3 May 2019
|
CS-430.1 Sepax Kit Sterility indicator, Biosafe SA (HSA 600:41/01-145/19/03_38)
Local Contact: Medquest Marketing Pte Ltd
Contact No./Email: 6805 1250
|
HSA 6004101-145-19-03_38 FSN_Redacted520 KB
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3 May 2019
|
Philips Affiniti 70 Diagnostic Ultrasound Systems, Philips Affiniti Diagnostic Ultrasound System, Philips EPIQ Diagnostic Ultrasound System and Philips EPIQ Ultrasound System, Philips Ultrasound, Inc (HSA 600:41/01-026/19/14_66)
Local Contact: Philips Electronics Singapore Pte Ltd
Contact No./Email: 1800 744 5477
|
HSA 6004101-026-19-14_66 FSN_Redacted131 KB
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3 May 2019
|
Covidien Emprint™ Percutaneous and SX Navigation Antenna with Thermosphere™ Technology, Covidien llc (HSA 600:41/01-046/19/05_64)
Local Contact: Covidien Pte Ltd
Contact No./Email: 6439 6974
|
HSA 6004101-046-19-05_64 FSN_Redacted188 KB
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3 May 2019
|
Coated Vicryl Plus Absorbable Surgical Suture, Ethicon, Inc (HSA 600:41/01-002/19/10_71)
Local Contact: Johnson & Johnson Pte Ltd
Contact No./Email: 6918 6717
|
HSA 6004101-002-19-10_71 FSN_Redacted169 KB
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3 May 2019
|
Ethicon PDS* PLUS Antibacterial (Polydioxanone) Suture, Ethicon, Inc (HSA 600:41/01-002/19/09_56)
Local Contact: Johnson & Johnson Pte Ltd
Contact No./Email: 6918 6717
|
HSA 6004101-002-19-09_56 FSN_Redacted189 KB
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2 May 2019
|
Thio Med w/Dex,Hem,Vit K and Thio Med w/Dex,Hemin,Vit K, Remel Inc (Thermo Fisher Scientific) (HSA 600:41/01-178/19/02_75)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact No./Email: 6499 9999 / cs.mbd.sg@thermofisher.com
|
HSA 6004101-178-19-02_75 FSN_Redacted117 KB
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2 May 2019
|
Aisys Anesthesia Devices and Aisys CS2 Anesthesia Devices, Datex-Ohmeda, Inc. (HSA 600:41/01-010/19/11_48)
Local Contact: GE Healthcare
Contact No./Email: 6277 7668 / svc@ge.com
|
HSA 6004101-010-19-11_48 FSN_Redacted147 KB
|
| 9 Apr 2019 |
Philips IntelliVue MX40, Philips Medical Systems (HSA 600:41/01-026/19/11_48)
Local Contact: Philips Electronic (Singapore) Pte Ltd
Contact No./Email: 1800 744 5477 |
HSA 6004101-026-19-11_48 FSN 2326 KB
This FSN is an update to the original FSN published in April 2019.
|
| 21 Nov 2018 |
Efficia 3/5 ECG Trunk Cable, Philips Goldway (Shenzhen) Industrial Inc. (HSA 600:41/01-026/18/32_62)
Local Contact: Philips Electronics (S) Pte Ltd
Contact No./Email: 1800 744 5477
|
HSA 6004101-026-18-32_62 FSN1446 KB
This updated FSN replaces the original FSN published in Nov 2018.
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