Date of Notification | Title | FSN |
|---|
30 Jun 2017 | Trauma, Guide Wires 70cm, Zimmer, Inc. (HSA 600:41/01-008/17/08_35)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7250 | HSA 6004101-008-17-08_35 FSN_Redacted [PDF, 360 KB] |
30 Jun 2017 | Oxoid GC Agar, ThermoFisher Scientific (HSA 600:41/01-178/17/02_67)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6499 9999 / cs.mbd.sg@thermofisher.com | HSA 6004101-178-17-02_67 FSN_Redacted [PDF, 158 KB] |
30 Jun 2017 | S-ICD system, Boston Scientific Corporation (HSA 600:41/01-007/17/07_37)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / singapore_fsca_query@bsci.com | HSA 6004101-007-17-07_37 FSN_Redacted [PDF, 112 KB] |
30 Jun 2017 | Zimmer® M/DN® Intramedullary Fixation System; Zimmer® Natural Nail™ System, Zimmer, Inc. (HSA 600:41/01-008/17/06_25)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7250 | HSA 6004101-008-17-06_25 FSN_Redacted [PDF, 450 KB] |
30 Jun 2017 | Trauma & Extremity Instruments (Drill bits and Screw taps), Zimmer Biomet, Inc. (HSA 600:41/01-008/17/07_19)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7250 | HSA 6004101-008-17-07_19 FSN_Redacted [PDF, 372 KB] |
30 Jun 2017 | Cobas e411 analyzer, Roche Diagnostics GmbH (HSA 600:41/01-016/17/13_59)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com | HSA 6004101-016-17-13_59_FSN [PDF, 207 KB] |
30 Jun 2017 | COULTER LH 750 ANALYZER, COULTER LH 780 ANALYZER, COULTER LH500 ANALYZER, COULTER HMX CP ANALYZERS, & COULTER HMX AL ANALYZERS, Beckman Coulter Inc. (HSA 600:41/01-052/17/08_34)
Local Contact:Beckman Coulter Singapore Pte Ltd
Contact no./Email: 6340 7126 | HSA 6004101-052-17-08_34_FSN_Redacted [PDF, 245 KB] |
29 Jun 2017 | ARCHITECT T-Update reagent, Abbott Laboratories (HSA 600:41/01-005/17/08_59)
Local Contact: Abbott Laboratories Pte Ltd
Contact no./Email: 6941 8000 / FSN@enquiry@abbott.com | HSA 6004101-005-17-08_59_FSN [PDF, 129 KB] |
27 Jun 2017 | Zenith Alpha Thoracic Endovascular Graft, William Cook Europe Aps (HSA 600:41/01-013/17/05_64)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com | HSA 6004101-013-17-05_64 FSN_Redacted [PDF, 425 KB] |
23 Jun 2017 | Beckman Coulter PK7300 Automated Microplate System, Beckman Coulter Inc (HSA 600:41/01-052/17/07_65)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 6340 7126 | HSA 6004101-052-17-07_65_FSN_Redacted [PDF, 92 KB] |
23 Jun 2017 | DLP® Extension Line Adapters 20 in length, DLP® Antegrade/Retrograde Adapter, DLP® Cardioplegia Adapter with Pressure Port, DLP® Pressure Monitoring Extension Line Adapters and DLP® Pressure Disposable Pressure Display Sets, Medtronic Inc. (HSA 600:41/01-009/17/11_37)
Local Contact: Medtronic International Ltd
Contact no./Email: 6436 5077 | HSA 6004101-009-17-11_37_FSN [PDF, 299 KB] |
21 Jun 2017 | ASP6025 Tissue Processor, Leica Biosystems Nussloch GmbH (HSA 600:41/01-126/17/01_61)
Local Contact: Leica Microsystems (SEA) Pte Ltd
Contact no./Email: 6550 5505 | HSA 6004101-126-17-01_61 FSN_Redacted [PDF, 1287 KB] |
21 Jun 2017 | Datascope Intra-aortic Balloon Pumps, Datascope Corp (HSA 600:41/01-081/17/01_56)
Local Contact: Maquet South East Asia Pte Ltd
Contact no./Email: 6296 1992 | HSA 6004101-081-17-01_56 FSN_Redacted [PDF, 93 KB] |
19 Jun 2017 | Alaris Pump module Model 8100, CareFusion (HSA 600:41/01-087/17/02_40)
Local Contact: Scanmed Technology (S) Pte Ltd
Contact no./Email: 6872 3660 / info@scanmed.com.sg | HSA 6004101-087-17-02_40_FSN_Redacted [PDF, 2267 KB] |
15 Jun 2017 | Stagbeetle Forceps Ratchet Lock, L 125mm, Synthes GmbH (HSA 600:41/01-002/17/07_54)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 7781 | HSA 6004101-002-17-07_54 FSN_Redacted [PDF, 1170 KB] |
15 Jun 2017 | Alaris® PC unit model 8015, CareFusion 303 Inc (HSA 600:41/01-003/17/13_46)
Local Contact: Becton Dickinson Holdings Pte. Ltd. (BD)
Contact no./Email: 6432 2048 | HSA 6004101-003-17-13_46 FSN_Redacted [PDF, 451 KB] |
15 Jun 2017 | Boston Scientific Encore 26 Inflation Device, Boston Scientific Corporation (HSA 600:41/01-007/17/06_48)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com | HSA 6004101-007-17-06_48 FSN [PDF, 2789 KB] |
15 Jun 2017 | ACUSON S Family ultrasound, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/17/21_43)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-heathineers.com | HSA 6004101-022-17-21_43 FSN [PDF, 126 KB] |
14 Jun 2017 | Medtronic Navlock Tracker used with StealthStation S7, Medtronic Navigation, Inc (HSA 600:41/01-009/17/10_52)
Local Contact: Medtronic International Ltd
Contact no./Email: 6439 6932 | HSA 6004101-009-17-10_52 FSN_Redacted [PDF, 353 KB] |
13 Jun 2017 | VITROS Chemistry Products PHYT Slides, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/17/08_60)
Local Contact: ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD
Contact no./Email: 6486 1151 | HSA 6004101-303-17-08_60 FSN_Redacted [PDF, 2715 KB] |
12 Jun 2017 | Alaris Pump module Model 8100, Carefusion 303 Inc (HSA 600:41/01-003/17/12_49)
Local Contact: Becton Dickinson Holdings Ptd Ltd
Contact no./Email: 6432 2048 | HSA 6004101-003-17-12_49 FSN_Redacted [PDF, 2269 KB] |
12 Jun 2017 | ARTIS, X-WORKPLACE, SENSIS AND ARCADIA SYSTEMS, Siemens Shenzhen Magnetic Resonance Ltd, Siemens Healthcare GmbH (HSA 600:41/01-022/17/20_63)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com | HSA 6004101-022-17-20_63 FSN_Redacted [PDF, 1825 KB] |
12 Jun 2017 | ADVIA Centaur Systems Calibrator 30, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/17/19_59)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com | HSA 6004101-022-17-19_59 FSN [PDF, 181 KB] |
09 Jun 2017 | ALARIS & ASENA (GS, GH, CC, TIVA, PK) SYRINGE PUMPS, CareFusion (HSA 600:41/01-087/17/01_19)
Local Contact: Scanmed Technology (S) Pte Ltd
Contact no./Email: 6872 3660 / info@scanmed.com.sg | HSA 6004101-087-17-01_19 FSN_Redacted [PDF, 138 KB] |
09 Jun 2017 | Pall Ultipor Breathing System Filter, Pall Medical (HSA 600:41/01-310/17/01_56)
Local Contact: Pall Filtration Pte Ltd
Contact no./Email: 63896500 | HSA 6004101-310-17-01_56 FSN_Redacted [PDF, 216 KB] |
08 Jun 2017 | Thoratec HeartMate 3 Left Ventricular Assist System Implant Kit, Thoratec Corporation (HSA 600:41/01-070/17/11_51)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com | HSA 6004101-070-17-11_51 FSN_Redacted [PDF, 28 KB] |
08 Jun 2017 | Astral 100 and Astral 150, Resmed Ltd (HSA 600:41/01-275/17/01_45)
Local Contact: Resmed Asia Operations P/L (Singapore Branch)
Contact no./Email: 6572 5936 | HSA 6004101-275-17-01_45 FSN_Redacted [PDF, 1530 KB] |
06 Jun 2017 | BD Phoenix™ AP Instrument, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/17/11_50)
Local Contact: Becton Dickinson Holdings Pte. Ltd. (BD)
Contact no./Email: 6432 2048 | HSA 6004101-003-17-11-50 FSN_Redacted [PDF, 37 KB] |
05 Jun 2017 | Axiom Artis, Artis Zee and Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/17/18_50)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com | HSA 6004101-022-17-18_50 FSN_Redacted [PDF, 1596 KB] |
05 Jun 2017 | Pepsinogen II ELISA Kit, Biohit Oyj (HSA 600:41/01-086/17/01_38)
Local Contact: SPD Scientific Pte Ltd
Contact no./Email: 6303 9877 / operations@spdscientific.com | HSA 6004101-086-17-01-38 FSN_Redacted [PDF, 219 KB] |
05 Jun 2017 | LABScreen Multi, One Lambda, Inc (HSA 600:41/01-033/17/03_31)
Local Contact: Biomed Diagnostics Pte Ltd
Contact no./Email: 6298 4347 / biomed.regulatory@biomed-global.com | HSA 6004101-033-17-03_31 FSN_Redacted [PDF, 306 KB] |
05 Jun 2017 | Multigent Creatinine (Enzymatic), Sentinel CH. SpA (HSA 600:41/01-005/17/07_23)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8290 / FSN_enquiry@abbott.com | HSA 6004101-005-17-07_23 FSN [PDF, 100 KB] |
02 Jun 2017 | CARBON DIOXIDE (CO) / OXYGEN (O2) TERMINAL UNITS - DIN STANDARD, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/17/03_44)
Local Contact: DRAEGER SINGAPORE PTE. LTD.
Contact no./Email: 6872 9288 / draeger.sg@draeger.com | HSA 6004101-063-17-03_44 FSN [PDF, 4006 KB] |
02 Jun 2017 | Draeger Infinity Acute Care System (IACS), Draeger Medical Systems, Inc. (HSA 600:41/01-063/17/02_18)
Local Contact: DRAEGER SINGAPORE PTE. LTD.
Contact no./Email: 6872 9288 / draeger.sg@draeger.com | HSA 6004101-063-17-02-18 FSN [PDF, 567 KB] |
02 Jun 2017 | BD Hypodermic Syringes with Needles, Becton Dickinson and Company (BD) (HSA 600:41/01-003/17/10_50)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 6432 2048 | HSA 6004101-003-17-10_50 FSN_Redacted [PDF, 188 KB] |
02 Jun 2017 | Equinoxe Modular and Non-Modular Pilot Tip Reamers, Exactech Inc (HSA 600:41/01-257/17/02_54)
Local Contact: Exactech Pte Ltd
Contact no./Email: 6273 0091 | HSA 6004101-257-17-02-54 FSN_Redacted [PDF, 228 KB] |
01 Jun 2017 | Boston Scientific Extractor Pro Retrieval Balloon Catheter, Boston Scientific Corporation (HSA 600:41/01-007/17/05_63)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email:6418 8888 / Singapore_FSCA_Query@bsci.com | HSA 6004101-007-17-05_63 FSN_Redacted [PDF, 40 KB] |
