Date of Notification | Title | FSN |
|---|
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 [PDF, 378 KB] |
30 Apr 2018 | Intuitive Surgical’s da Vinci Xi Stapler 45 Blue and Green Reloads, Intuitive Surgical, Inc (HSA 600:41/01-070/18/06_35)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com | HSA 6004101-070-18-06_35 FSN [PDF, 386 KB] |
30 Apr 2018 | Aurinio L 110, L 120, L 150 and L 160, Aurinio OR lights series, Trilux Medical GmbH & Co. KG (HSA 600:41/01-099/18/01_45)
Local Contact: Leedon Technology Pte Ltd
Contact no./Email: 6284 8382/ leedon28@singnet.com.sg | HSA 6004101-099-18-01_45 FSN_Redacted [PDF, 3054 KB] |
28 Apr 2018 | T2 Femur and Tibia Nailing System, Stryker Trauma GmbH (HSA 600:41/01-014/18/05_66)
Local Contact: Stryker Singapore Pte Ltd | HSA 6004101-014-18-05_66 FSN_Redacted [PDF, 129 KB] |
27 Apr 2018 | Artis Zee Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/18/10_45)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com | HSA 6004101-022-18-10_45 FSN_Redacted [PDF, 1100 KB] |
27 Apr 2018 | Covidien ENDO GIA™ UNIVERSAL Stapler and Duet TRS™ Single Use Loading Units with Tissue Reinforcement, Covidien Endo GIA™ Ultra Universal Stapler and Endo GIA™ Reload with Tri-Staple™ Technology, Covidien llc (HSA 600:41/01-046/18/05_18)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6933 | HSA 6004101-046-18-05_18 FSN_Redacted [PDF, 4215 KB] |
27 Apr 2018 | Urisys 1100 , Roche Diagnostics GmbH (HSA 600:41/01-016/18/04_61)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com | HSA 6004101-016-18-04_61 FSN [PDF, 119 KB] |
26 Apr 2018 | Elements Obturation Unit with Buchanan Heat Pluggers, SybronEndo (HSA 600:41/01-168/18/01_71)
Local Contact: KaVo Dental Asia Pacific Pte Ltd
Contact no./Email: 6296 1790 | HSA 6004101-168-18-01_71 FSN_Redacted [PDF, 306 KB] |
26 Apr 2018 | CLARUS 500, Carl Zeiss Meditec Inc. (HSA 600:41/01-136/18/01_64)
Local Contact: Carl Zeiss Pte. Ltd.
Contact no./Email: 6741 9600 / info@zeiss.com.sg | HSA 6004101-136-18-01_64 FSN [PDF, 112 KB] |
25 Apr 2018 | Acid Concentrate for Bicarbonate Haemodialysis, Fresenius Medical Care Production Sdn Bhd (HSA 600:41/01-062/18/01_68)
Local Contact: Fresenius Medical Care Singapore Pte Ltd
Contact no./Email: 6837 3113 | HSA 6004101-062-18-01_68 FSN_Redacted [PDF, 1283 KB] |
25 Apr 2018 | Bard Seeker Crossing Support Catheter, Bard Peripheral Vascular, Inc (HSA 600:41/01-050/18/02_18)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: 6580 5988 / complaints.singapore@crbard.com | HSA 6004101-050-18-02_18 FSN_Redacted [PDF, 382 KB] |
25 Apr 2018 | ThermoScientific Oxoid OX1 Oxacillin, Oxoid Limited (HSA 600:41/01-178/18/02_34)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6362 9390 | HSA 6004101-178-18-02_34 FSN_Redacted [PDF, 117 KB] |
24 Apr 2018 | Alinity I HBsAg Calibrator, Abbott Ireland Diagnostics Division (HSA 600:41/01-005/18/05_59)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8000 / FSN@enquiry@abbott.com | HSA 6004101-005-18-05_59 FSN [PDF, 99 KB] |
24 Apr 2018 | ASKINA CALGITROL PASTE 15 G, B. Braun Hospicare Ltd (HSA 600:41/01-012/18/02_56)
Local Contact: B. Braun Singapore Pte Ltd
Contact no./Email: 6213 0933 / press.sg@bbraun.com | HSA 6004101-012-18-02_56 FSN [PDF, 53 KB] |
24 Apr 2018 | BD Vacutainer® EDTA Blood Collection Tubes, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/18/05_58)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 6690 8423 | HSA 6004101-003-18-05_58 FSN_Redacted [PDF, 208 KB] |
24 Apr 2018 | CPFA Coupled Plasma Filtration Adsorption™, Covidien llc (HSA 600:41/01-046/18/04_46)
Local Contact: Covidien Pte Ltd
Contact no./Email: Tel: 64396974 | HSA 6004101-046-18-04_46 FSN_Redacted [PDF, 696 KB] |
20 Apr 2018 | 5mm ENDOPATH® XCEL™ Trocars with Optiview Technology, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/18/04_63)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 8304 | HSA 6004101-002-18-04_63 FSN_Redacted [PDF, 631 KB] |
20 Apr 2018 | AdvanceTM Low Profile PTA Balloon Dilatation Catheter, Cook Incorporated (HSA 600:41/01-013/18/04_51)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com | HSA 6004101-013-18-04_51 FSN_Redacted [PDF, 127 KB] |
20 Apr 2018 | CHISEL MICRO CURVED VULCAN INTEGRATED; CHISEL MICRO VULCAN ANGLED INTEGRATED, Smith & Nephew, Inc. (HSA 600:41/01-073/18/09_63)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-18-09_63 FSN [PDF, 192 KB] |
20 Apr 2018 | Smith & Nephew TAYLOR SPATIAL FRAME External Fixator, Smith & Nephew, Inc. (HSA 600:41/01-073/18/10_50)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-18-10_50 FSN [PDF, 174 KB] |
20 Apr 2018 | SOMA TOM go.Up and SOMA TOM go.Now, Siemens Shanghai Medical Equipment Ltd (HSA 600:41/01-022/18/09_46)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com | HSA 6004101-022-18-09_46 FSN_Redacted [PDF, 2486 KB] |
19 Apr 2018 | 1. Merlin PCS 3650 Software Upgrade Kit
2. Merlin@home Transmitter Software
3. High Voltage Device ICD and CRT-D (model name Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, Unify Quadra™, Promote Quadra™ and Ellipse™)
St. Jude Medical, Cardiac Rhythm Management Division (HSA 600:41/01-025/18/01_51)
Local Contact: St Jude Medical (Singapore) Pte Ltd
Contact no./Email: 6643 2800 | HSA 6004101-025-18-01_51 FSN_Redacted [PDF, 548 KB] |
19 Apr 2018 | Cardiovit AT-102 Plus, Schiller AG (HSA 600:41/01-056/18/02_50)
Local Contact: Gold Lite Pte Ltd
Contact no./Email: 6273 0487 | HSA 6004101-056-18-02_50 FSN_Redacted [PDF, 470 KB] |
18 Apr 2018 | MyLab Twice, Esaote (HSA 600:41/01-288/18/01_64)
Local Contact: Medical Plus Pte Ltd | HSA 6004101-288-18-01_64 FSN_Redacted [PDF, 107 KB] |
17 Apr 2018 | Portex Thoracic Catheter and Connecting Tube, Smiths Medical International, Ltd. (HSA 600:41/01-017/18/02_40)
Local Contact: IDS Medical Systems (S) Pte Ltd | HSA 6004101-017-18-02_40 FSN [PDF, 323 KB] |
17 Apr 2018 | TerumoBCT Spectra Optia® Apheresis System, TerumoBCT (HSA 600:41/01-155/18/01_36)
Local Contact: TERUMO BCT ASIA PTE. LTD
Contact no./Email: 67739051 / apac.communications@terumobct.com | HSA 6004101-155-18-01_36 FSN_Redacted [PDF, 409 KB] |
17 Apr 2018 | Peri-Loc 3.5MM Posterolateral Distal Fibula Locking Plate, Smith & Nephew Inc. (HSA 600:41/01-073/18/08_43)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-18-08_43 FSN [PDF, 174 KB] |
16 Apr 2018 | Sciatic Nerve Retractors, Synthes GmbH (HSA 600:41/01-002/18/03_49)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 8304 | HSA 6004101-002-18-03_49 FSN_Redacted [PDF, 253 KB] |
13 Apr 2018 | Various Arrow Products, Arrow International, Inc (HSA 600:41/01-139/18/01_35)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact no./Email: 6439 3046 | HSA 6004101-139-18-01_35 FSN_Redacted [PDF, 316 KB] |
13 Apr 2018 | Bio-Rad DiaMed ID-Card LISS Coombs and Bio-Rad DiaMed ID-Card Anti-IgG, DiaMed GmbH (HSA 600:41/01-027/18/04_58)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262 | HSA 60041-01-027-18-04_58 FSN_Redacted [PDF, 3445 KB] |
12 Apr 2018 | Connecting Tube – Female to Male Luer Lock, Cook Incorporated (HSA 600:41/01-013/18/03_35)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com | HSA 6004101-013-18-03_35 FSN_Redacted [PDF, 114 KB] |
12 Apr 2018 | Ethicon Generator Gen11, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/18/02_37)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 7781 | HSA 6004101-002-18-02_37 FSN_Redacted [PDF, 531 KB] |
12 Apr 2018 | Flexor Tuohy Borst Side-Arm Introducer Shuttle SL, Cook Incorporated (HSA 600:41/01-013/18/02_62)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com | HSA 6004101-013-18-02_62 FSN_Redacted [PDF, 110 KB] |
11 Apr 2018 | Gentinge Volista StandOP and TRIOP, Maquet SAS (HSA 600:41/01-081/18/04_45)
Local Contact: Maquet South East Asia Pte Ltd
Contact no./Email: 6296 1992 | HSA 6004101-081-18-04_45 FSN [PDF, 201 KB] |
10 Apr 2018 | ARCHITECT Total T4 Calibrators, Abbott Ireland, Diagnostics Division (HSA 600:41/01-005/18/04_38)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 / 8000 / FSN@enquiry@abbott.com | HSA 6004101-005-18-04_38 FSN [PDF, 109 KB] |
10 Apr 2018 | Covidien EEA™ Hemorrhoid and Prolapse Stapler Set with DST Series™ Technology, Covidien llc (HSA 600:41/01-046/18/03_66)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6933 | HSA 6004101-046-18-03_66 FSN_Redacted [PDF, 1397 KB] |
10 Apr 2018 | BD Vacutainer Blood Collection Tubes, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/18/04_31)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 6690 8423 | HSA 6004101-003-18-04_31 FSN_Redacted [PDF, 294 KB] |
10 Apr 2018 | DISCOVERY IGS 730/740, INNOVA IGS 620/630/520/530/540 SYSTEMS, Datex-Ohmeda Inc. (HSA 600:41/01-010/18/08_25)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com | HSA 6004101-010-18-08_25 FSN_Redacted [PDF, 467 KB] |
09 Apr 2018 | Pulsar-18, Peripheral self-expanding Nitinol stent system, Biotronik AG (HSA 600:41/01-269/18/01_37)
Local Contact: Biotronik Asia Pacific Pte Ltd
Contact no./Email: 6228 9869 | HSA 6004101-269-18-01_37 FSN [PDF, 87 KB] |
09 Apr 2018 | Draeger Jaundice Meter, Model JM-103 & Draeger Jaundice Meter JM-105, Draeger Medical Systems, Inc. (HSA 600:41/01-063/18/04_71)
Local Contact: Draeger Singapore Pte Ltd
Contact no./Email: 6872 9288 / draeger.sg@draeger.com | HSA 6004101-063-18-04_71 FSN-01_Redacted [PDF, 5351 KB] |
06 Apr 2018 | Thoratec HeartMate III™ LVAS Implant Kit, Thoratec Corporation (HSA 600:41/01-070/18/05_68)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com | HSA 6004101-070-18-05_68 FSN_Redacted [PDF, 69 KB] |
06 Apr 2018 | LEICA PROVEO 8 OPHTHALMIC MICROSCOPE SYSTEM, Leica Microsystems AG (HSA 600:41/01-126/18/01_64)
Local Contact: Leica Instruments Pte Ltd
Contact no./Email: 6550 5912 | HSA 6004101-126-18-01_64 FSN_Redacted [PDF, 1462 KB] |
06 Apr 2018 | ADVIA® Chemistry Systems Urea Nitrogen (UN), Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/18/08_23)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com | HSA 6004101-022-18-08_23 FSN [PDF, 130 KB] |
05 Apr 2018 | Heartware Left Ventricular Assist Device, HeartWare Inc. (HSA 600:41/01-263/18/01_18)
Local Contact: Emergo Consulting Pte Ltd
Contact no./Email: 6832 5625 / SEAvigilance@emergogroup.com | HSA 6004101-263-18-01_18 FSN_Redacted [PDF, 142 KB] |
05 Apr 2018 | Brilliance Big Bore/Ingenuity CT/Ingenuity Core/Ingenuity Core 128, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/18/14_52)
Local Contact: Philips Electronics(s) Pte Ltd
Contact no./Email: 1800 744 5477 | HSA 6004101-026-18-14_52 FSN_Redacted [PDF, 518 KB] |
05 Apr 2018 | T2100 Treadmill Microflex drive, GE Medical Systems Information Technologies, Inc. (HSA 600:41/01-010/18/07_62)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com | HSA 6004101-010-18-07_62 FSN_Redacted [PDF, 420 KB] |
05 Apr 2018 | PR4100 Magellan Software, Bio-Rad Laboratories Inc (HSA 600:41/01-027/18/03_70)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262 | HSA 6004101-027-18-03_70 FSN [PDF, 93 KB] |
04 Apr 2018 | BD Vacutainer Plus Citrate Plasma Tube, Becton Dickinson & Company (HSA 600:41/01-003/18/03_70)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 6690 8423 | HSA 6004101-003-18-03_70 FSN_Redacted [PDF, 3237 KB] |
03 Apr 2018 | Legion CR High Flex XLPE, Smith & Nephew Inc. (HSA 600:41/01-073/18/07_40)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-18-07_40 FSN [PDF, 175 KB] |
02 Apr 2018 | Vivid and LOGIQ ultrasound systems, GE Vingmed Ultrasound / GE Medical Systems (HSA 600:41/01-010/18/06_56)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com | HSA 6004101-010-18-06_56 FSN_Redacted [PDF, 308 KB] |
02 Apr 2018 | Apple Medical Hunt Secondary Cannula/ Trocar, CooperSurgical (HSA 600:41/01-057/18/01_46)
Local Contact: Somnotec (S) Pte Ltd
Contact no./Email: 6844 0002 / info@somnotec.net | HSA 6004101-057-18-01_46 FSN_Redacted [PDF, 3499 KB] |
