Date of Notification | Title | FSN |
|---|
29 Jun 2018 | Terumo® Advanced Perfusion System 1, Terumo Cardivascular Systems Corporation (HSA 600:41/01-028/18/03_71)
Local Contact: Terumo Singapore Pte Ltd
Contact no./Email: 62913603 | HSA 6004101-028-18-03_71 FSN [PDF, 960 KB] |
28 Jun 2018 | Neonatal Flow Sensor Cable, Datex-Ohmeda Inc (HSA 600:41/01-010/18/15_64)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com | HSA 6004101-010-18-15_64 FSN_Redacted [PDF, 387 KB] |
27 Jun 2018 | EnTrust® and Escudo® VR/DR/AT ICDs, Medtronic Inc (HSA 600:41/01-009/18/10_68)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5077 | HSA 6004101-009-18-10_68 FSN_Redacted [PDF, 404 KB] |
26 Jun 2018 | Schiller Medical DEFIGARD Touch 7, Schiller Medical S.A.S. (HSA 600:41/01-056/18/03_71)
Local Contact: Gold Lite Pte Ltd
Contact no./Email: 62730487 | HSA 6004101-056-18-03_71 FSN_Redacted [PDF, 241 KB] |
26 Jun 2018 | CARESCAPE Monitor B650, GE Healthcare Finland Oy (HSA 600:41/01-010/18/14_56)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668 / svc@ge.com | HSA 6004101-010-18-14_56 FSN_Redacted [PDF, 345 KB] |
26 Jun 2018 | Dialine ALAT (ALT/GPT), Dialine CK-MB, BioRex ALAT (ALT/GPT), Dialine Diagnostic Systems Pte Ltd, BioREX MANNHEIM Diagnostics (HSA 600:41/01-326/18/02_31)
Local Contact: Dialine Diagnostic Systems Pte Ltd
Contact no./Email: 6747 2009 | HSA 6004101-326-18-02_31 FSN [PDF, 150 KB] |
26 Jun 2018 | Arctic Sun 5000 Temperature Management Systems, Medivance, Inc (HSA 600:41/01-050/18/04_62)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: 6580 5988 / Complaints.Singapore@crbard.com | HSA 6004101-050-18-04_62 FSN_Redacted [PDF, 435 KB] |
26 Jun 2018 | Arrow® HANDS-OFF® Thermodilution Catheter, Arrow International (HSA 600:41/01-139/18/02_51)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact no./Email: 6439 3046 | HSA 6004101-139-18-02_51 FSN_Redacted [PDF, 153 KB] |
26 Jun 2018 | Percepta™ CRT-P MRI SureScan™ and Percepta™ Quad CRT-P MRI SureScan™ Pacemakers, Medtronic Inc (HSA 600:41/01-009/18/09_38)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5077 | HSA 6004101-009-18-09_38 FSN_Redacted [PDF, 258 KB] |
26 Jun 2018 | ATP Hexokinase FS, DiaSys Diagnostic Systems GmbH (HSA 600:41/01‐326/18/01_23)
Local Contact: Dialine Diagnostic Systems Pte Ltd
Contact no./Email: 6747 2009 | HSA 6004101-326-18-01_23 FSN [PDF, 263 KB] |
25 Jun 2018 | MAC-LAB, CARDIOLAB, COMBOLAB AND SPECIALSLAB RECORDING SYSTEMS, GE Medical Systems Information Technologies (HSA 600:41/01‐010/18/13_66)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com | HSA 6004101-010-18-13_66 FSN_Redacted [PDF, 331 KB] |
22 Jun 2018 | MobileDiagnost wDR, Philips Medical Systems (HSA 600:41/01-026/18/19_68)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email:1800 744 5477 | HSA 6004101-026-18-19_68 FSN_Redacted [PDF, 61 KB] |
22 Jun 2018 | Philips Digital Diagnost Radiography System, Philips Medical Systems DMC GmbH (HSA 600:41/01-026/18/20_46)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477 | HSA 6004101-026-18-20_46 FSN_Redacted [PDF, 1251 KB] |
22 Jun 2018 | Single Chamber Temporary External Pacemaker 53401, Medtronic Inc (HSA 600:41/01-009/18/08_18)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5077 | HSA 6004101-009-18-08_18 FSN_Redacted [PDF, 1156 KB] |
21 Jun 2018 | ArtisQ and Artis Pheno system, Siemens Healthcare GmbH (HSA 600:41/01-022/18/14_50)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com | HSA 6004101-022-18-14_50 FSN Redacted [PDF, 2362 KB] |
20 Jun 2018 | Vigileo, Vigilance II and EV1000A Monitor, Edwards Lifesciences LLC (HSA 600:41/01-060/18/01_44)
Local Contact: Edwards Lifesciences (Asia) Pte Ltd
Contact no./Email: 8128 0211 | HSA 6004101-060-18-01_44 FSN_Redacted [PDF, 1037 KB] |
20 Jun 2018 | LEGION HK TIBIAL BASE SZ 5 LEFT, Smith & Nephew, Inc. (HSA 600:41/01-073/18/15_46)
Local Contact: SMITH & NEPHEW PTE LIMITED
Contact no./Email:6270 0552 / singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-18-15_46 FSN [PDF, 116 KB] |
20 Jun 2018 | Maestro 4000 Cardiac Ablation System Optional Foot Switch, Boston Scientific Corporation (HSA 600:41/01-007/18/04_63)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@bsci.com | HSA 6004101-007-18-04_63 FSN_Redacted [PDF, 316 KB] |
20 Jun 2018 | Intertan 11.5mmx18cm 125D, Smith & Nephew, Inc.(HSA 600:41/01-073/18/14_50)
Local Contact: SMITH & NEPHEW PTE LIMITED
Contact no./Email:6270 0552 / singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-18-14_50 FSN [PDF, 118 KB] |
19 Jun 2018 | Discovery MR750w, GE Healthcare (HSA 600:41/01-010/18/12_35)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com | HSA 6004101-010-18-12_35 FSN_Redacted [PDF, 295 KB] |
15 Jun 2018 | Stryker Synchro² Guidewires, Stryker Neurovascular (HSA 600:41/01-070/18/09_37)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com | HSA 6004101-070-18-09_37 FSN_Redacted [PDF, 1654 KB] |
14 Jun 2018 | Covidien Puritan-Bennett 800 Series Ventilator System, Covidien Newport e360 Ventilator, Covidien llc (HSA 600:41/01-046/18/08_44)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6974 | HSA 6004101-046-18-08_44 FSN [PDF, 90 KB] |
13 Jun 2018 | Allura Xper, UNIQ and Centron, Philips Medical Systems Nederland BV (HSA 600:41/01-026/18/18_45)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477 | HSA 6004101-026-18-18_45 FSN Redacted [PDF, 1458 KB] |
12 Jun 2018 | B.Braun Novosyn® Absorbable Surgical Suture and B.Braun Safil® Absorbable Surgical Suture, B. Braun Surgical SA (HSA 600:41/01-012/18/03_43)
Local Contact: B. Braun Singapore Pte Ltd
Contact no./Email: 6213 0933 / press.sg@bbraun.com | HSA 6004101-012-18-03_43 FSN Redacted [PDF, 863 KB] |
12 Jun 2018 | Cardinal Health Hydroline Trumpet Valves, Cardinal Health (HSA 600:41/01-307/18/01_18)
Local Contact: Cardinal Health Singapore 225 Pte Ltd
Contact no./Email: 6230 2362 | HSA 6004101-307-18-01_18 FSN_Redacted [PDF, 69 KB] |
12 Jun 2018 | Neomed Enteral Feeding Tubes, NeoMed Inc (HSA 600:41/01-012/18/04_64)
Local Contact: B. Braun Singapore Pte Ltd
Contact no./Email: 6213 0941 | HSA 6004101-012-18-04_64 FSN_Redacted [PDF, 2969 KB] |
11 Jun 2018 | GE Healthcare A1 Panel for CT and CT/PET scanners, GE Healthcare (HSA 600:41/01-010/18/11_51)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668 / svc@ge.com | HSA 6004101-010-18-11_51 FSN_Redacted [PDF, 624 KB] |
11 Jun 2018 | VITROS Chemistry Products Na+ Slides, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/18/07_49)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 6486 1151 | HSA 6004101-303-18-07_49 FSN_Redacted [PDF, 2771 KB] |
08 Jun 2018 | 150cm Y Extension Tube Dual Check Valve, Imaxeon Pty Ltd (HSA 600:41/01-069/18/01_66)
Local Contact: O’Connor’s Singapore Pte Ltd
Contact no./Email:6470 2000 / enquiries@oconnors.wbl.com.sg | HSA 6004101-069-18-01_66 FSN_Redacted [PDF, 111 KB] |
07 Jun 2018 | Volista Bracket, Maquet SAS (HSA 600:41/01-081/18/06_64)
Local Contact: IDS Medical System (Singapore) Pte Ltd
Contact no./Email: 6296 1992 | HSA 6004101-081-18-06_64 FSN [PDF, 305 KB] |
07 Jun 2018 | Tina-quant IgG Gen.2 on cobas c 311/501/502 analyzers, Roche Diagnostics GmbH (HSA 600:41/01-016/18/10_67)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com | HSA 6004101-016-18-10_67 FSN [PDF, 342 KB] |
07 Jun 2018 | Mega Power Electrosurgical Generator, Megadyne Medical Products Inc (HSA 600:41/01-325/18/01_71)
Local Contact: GiGATT International Marketing Pte Ltd
Contact no./Email: 65471713 / gigatt@gigatt.net | HSA 6004101-325-18-01_71 FSN Redacted [PDF, 14563 KB] |
07 Jun 2018 | qUAntify Control, qUAntify Plus Control, Bio-Rad Laboratories Inc (HSA 600:41/01-027/18/07_70)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262 | HSA 6004101-027-18-07_70 FSN [PDF, 112 KB] |
06 Jun 2018 | Visera Elite II Video System Center OTV-S200 / OTV-S300, Olympus Medical Systems Corp (HSA 600:41/01-004/18/02_46)
Local Contact: Olympus Singapore Pte Ltd
Contact no./Email: 6833 4214 / mes-ra.osp@olympus-ap.com | HSA 6004101-004-18-02_46 FSN_Redacted [PDF, 1202 KB] |
06 Jun 2018 | CORAIL® AMT Neck Trials Surgical Instruments, Depuy (Ireland) (HSA 600:41/01-002/18/06_38)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 8304 | HSA 6004101-002-18-06_38 FSN_Redacted [PDF, 370 KB] |
06 Jun 2018 | Suture Anchor Devices, Suture Passer Devices and Coblation Wands, Smith & Nephew Inc (HSA 600:41/01-073/18/13_35)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: 6270 0552 / singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-18-13_35 FSN [PDF, 196 KB] |
06 Jun 2018 | Sysmex AUTOMATED HEMATOLOGY ANALYZER XN SERIES XN-10 AND XN-20, Sysmex Corporation (HSA 600:41/01-032/18/01_57)
Local Contact: Sysmex Asia Pacific Pte. Ltd.
Contact no./Email: 6221 3629 / RA@sysmex-ap.com | HSA 6004101-032-18-01_57 FSN_Redacted [PDF, 3833 KB] |
05 Jun 2018 | MRSA Select II agar, Bio-Rad (HSA 600:41/01‐027/18/06_61)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262 | HSA 6004101-027-18-06_61 FSN_Redacted [PDF, 136 KB] |
04 Jun 2018 | GE Healthcare A1 Panel for Nuclear scanners, GE Medical Systems Israel, Functional Imaging (HSA 600:41/01-010/18/10_62)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com | HSA 6004101-010-18-10_62 FSN_Redacted [PDF, 388 KB] |
01 Jun 2018 | FHC Depth Stop Adapter, FHC Inc (HSA 600:41/01‐009/18/07_54)
Local Contact: Medtronic International Ltd
Contact no./Email: 6439 5000 | HSA 6004101009-18-07_54 FSN_Redacted [PDF, 616 KB] |
01 Jun 2018 | ALAT (GPT) FS (IFCC mod.), ATP Hexokinase FS, CK-MB FS, GLDH FS DGKC, DiaSys Diagnostic Systems Gmb (HSA 600:41/01-032/17/07_34)
Local Contact: Sysmex Asia Pacific Pte. Ltd.
Contact no./Email: 6221 3629 / RA@sysmex-ap.com | HSA 6004101-032-17-07_34 FSN [PDF, 267 KB] |
