Date of Notification | Title | FSN |
|---|
30 Nov 2017 | INTRO-FLEX SHEATH INTRODUCERS, Edwards Lifesciences (HSA 600:41/01-060/17/01_54)
Local Contact: Edwards Lifesciences (Asia) Pte Ltd | HSA 6004101-060-17-01_54 FSN [PDF, 111 KB] |
29 Nov 2017 | CADD Medication Cassette Reservoir, Smiths Medical ASD, Inc (HSA 600:41/01-017/17/05_51)
Local Contact: IDS Medical Systems (S) Pte Ltd | HSA 6004101-017-17-05_51 FSN_Redacted [PDF, 1458 KB] |
27 Nov 2017 | DiaSys Antistreptolysin O FS, DiaSys Diagnostic Systems GmbH (HSA 600:41/01-032/17/05_60)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 6221 3629 / RA@sysmex-ap.com | HSA 6004101-032-17-05_60 FSN [PDF, 409 KB] |
24 Nov 2017 | Abbott Alinity hq Analyzer, Abbott GmbH & Co. KG (HSA 600:41/01-005/17/24_60)
Local Contact: ABBOTT Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8290 / FSN_enquiry@abbott.com | HSA 6004101-005-17-24_60 FSN [PDF, 305 KB] |
24 Nov 2017 | Puritant Bennett 980 Ventilators Rechargeable Li-ion Batteries, Covidien llc (HSA 600:41/01-046/17/10_40)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6974 | HSA 6004101-046-17-10_40 FSN_Redacted [PDF, 976 KB] |
24 Nov 2017 | Accuray TomoTherapy Hi Art System, Accuray Incorporated (HSA 600:41/01-070/17/19_44)
Local Contact:Transmedic Pte Ltd
Contact no./Email: 64776101 / regulatory@transmedicgroup.com | HSA 6004101-070-17-19_44 FSN_Redacted [PDF, 3494 KB] |
23 Nov 2017 | Thermo Scientific™ Remel™ Shigella sonnei (Phases 1&2) Agglutinating Serum, Thermo Fisher Scientific (HSA 600:41/01-178/17/07_59)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6499 9999 / cs.mbd.sg@thermofisher.com | HSA 6004101-178-17-07_59_FSN_Redacted [PDF, 155 KB] |
23 Nov 2017 | Proteus 235 - Proton Therapy System, Ion Beam Applications S.A. (HSA 600:41/01-070/17/18_54)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6737 1945 / regulatory@transmedicgroup.com | HSA 6004101-070-17-18_54 FSN_edited [PDF, 225 KB] |
22 Nov 2017 | Cook Reuter Tip Deflecting Wire Guide DTDW, Cook Incorporated (HSA 600:41/01-013/17/06_68)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400; SNG-RegulatoryAffairs@cookmedical.com | HSA 6004101-013-17-06_68_FSN_Redacted [PDF, 938 KB] |
22 Nov 2017 | COOK Fallopian Tube Catheterization Sets, Cook Incorporated (HSA 600:41/01-013/17/07_71)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com | HSA 6004101-013-17-07_71 FSN_Redacted [PDF, 102 KB] |
21 Nov 2017 | Abbott Laboratories CELL-DYN Ruby System, Abbott Laboratories (HSA 600:41/01-005/17/23_58)
Local Contact: Abbott Laboratories Pte Ltd
Contact no./Email: 6914 8290 / FSN_enquiry@abbott.com | HSA 6004101-005-17-23_58 FSN [PDF, 343 KB] |
21 Nov 2017 | Stryker Instruments - multiple disposable products, Stryker Instruments (HSA 600:41/01-014/17/07_18)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: asean.pms@stryker.com | HSA 6004101-014-17-07_18 FSN [PDF, 138 KB] |
20 Nov 2017 | JETX BAR FREEDOM CLAMP 10.5MM TO 5MM, Smith & Nephew, Inc (HSA 600:41/01-073/17/17_46)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-17-17_46 FSN [PDF, 58 KB] |
17 Nov 2017 | Medtronic Synchromed II Programmable Drug Infusion System, Medtronic Inc. (HSA 600:41/01-009/17/22_63)
Local Contact: Medtronic International Ltd
Contact no./Email: 6436 5000 | HSA 6004101-009-17-22_63 FSN_Redacted [PDF, 194 KB] |
15 Nov 2017 | Polyganics Nasopore Dressing (Polyganics 8cm Nasal Dressing), Polyganics BV (HSA 600:41/01-264/17/01_50)
Local Contact:Easmed Asia Pte Ltd
Contact no./Email: 6471 3133 | HSA 6004101-264-17-01_50 FSN_Redacted [PDF, 1353 KB] |
14 Nov 2017 | DEFIGARD Touch 7, Schiller Medical S.A.S (HSA 600:41/01-056/17/06_36)
Local Contact:Gold Lite Pte Ltd
Contact no./Email: 6273 0487 | HSA 6004101-056-17-06_36 FSN_Redacted [PDF, 116 KB] |
13 Nov 2017 | Anaconda Longer Leg Iliac Stent Graft System, Vascutek Ltd (HSA 600:41/01-028/17/03_49)
Local Contact: Terumo Singapore Pte Ltd
Contact no./Email: 6291 3603 | HSA 6004101-028-17-03_49 FSN_Redacted [PDF, 961 KB] |
13 Nov 2017 | CLINITEK Novus®-to-Atellica® UAS 800 Rack Handler, Siemens Healthcare Diagnostics, Inc. (HSA 600:41/01-022/17/30_38)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com | HSA6004101-022-17-30_38 FSN [PDF, 16 KB] |
13 Nov 2017 | Infant/Child Reduced Energy Defibrillation Electrodes, Physio-Control (HSA 600:41/01-056/17/05_35)
Local Contact: Gold Lite Pte Ltd
Contact no./Email: 6273 0487 | HSA 6004101-056-17-05_35 FSN_Redacted [PDF, 227 KB] |
10 Nov 2017 | Covidien Puritan Bennett 980 Series Ventilator, Covidien Ilc (HSA 600:41/01-046/17/09_37)
Local Contact: Covidien Pte Ltd
Contact no./Email:6439 6974 | HSA 6004101-046-17-09_37 Customer Communication Letter [PDF, 80 KB] |
10 Nov 2017 | Integrity, Elekta Limited (HSA 600:41/01-101/17/09_19)
Local Contact: Elekta Pte Ltd
Contact no./Email: 6221 2322 / Elekta_Global_PMS@elekta.com | HSA 6004101-101-17-09_19 FSN_Redacted [PDF, 297 KB] |
08 Nov 2017 | Alinity Hq Analyzer, Abbott GmbH & Co. KG (HSA 600:41/01-005/17/22_69)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8290 / FSN_enquiry@abbott.com | HSA 6004101-005-17-22_69 FSN [PDF, 113 KB] |
06 Nov 2017 | MONOCLONAL MOUSE ANTI-HUMAN CDX2, CLONE DAK-CDX2, Dako North America Inc (HSA 600:41/01-086/17/02_67)
Local Contact: SPD Scientific Pte Ltd
Contact no./Email: 6303 9877 | HSA 6004101-086-17-02_67 FSN_Redacted [PDF, 486 KB] |
06 Nov 2017 | BiPAP A40, Respironics Inc. (HSA 600:41/01-317/17/01_25)
Local Contact: MedwoRx International Pte Ltd
Contact no./Email: 6853 3623 | HSA 6004101-317-17-01_25 FSN [PDF, 121 KB] |
06 Nov 2017 | ELUVIATM 150MM AND INNOVATM 180MM & 200MM STENT SYSTEMS, Boston Scientific Corporation (HSA 600:41/01-007/17/09_18)
Local Contact: Boston Scientific Asia Pacific Pte Ltd.
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com | HSA 6004101-007-17-09_18 FSN_Redacted [PDF, 3168 KB] |
03 Nov 2017 | cobas MRSA/SA Nucleic acid test, Roche Molecular Systems, Inc (HSA 600:41/01-016/17/18_61)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com | HSA 6004101-016-17-18_61 FSN [PDF, 335 KB] |
02 Nov 2017 | Somatom Definition, Definition AS/Edge/Flash/Force, Siemens Healthcare GmbH (HSA 600:41/01-022/17/29_64)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com | HSA 6004101-022-17-29_64 FSN_Redacted [PDF, 1938 KB] |
02 Nov 2017 | VITEK 2 GP ID Card, bioMérieux SA (HSA 600:41/01-146/17/12_23)
Local Contact: Biomerieux Singapore Pte Ltd
Contact no./Email: 6801 6706 | HSA 6004101-146-17-12_23 FSN [PDF, 833 KB] |
01 Nov 2017 | Fabius with Auxilliary Common Gas Outlet (ACGO), Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/17/05_62)
Local Contact: Draeger Singapore Pte Ltd
Contact no./Email: 6872 9288 | HSA 6004101-063-17-05_62 FSN_Redacted [PDF, 3873 KB] |
13 Oct 2017 | VITEK® 2 Gram-Positive (GP) Identification (ID) Test Kit, bioMérieux, Inc. (HSA 600:41/01-146/17/11_69)
Local Contact: BioMerieux Singapore Pte Ltd
Contact no./Email: 6801 6700 | HSA 6004101-146-17-11_69 FSN Update [PDF, 781 KB] |
