|
Date of Notification
|
Title
|
FSN
|
|
29 Apr 2016
|
Cortex Screw Ø 4.5mm, self-tapping, length 20mm, Pure Titanium, Synthes GmbH (HSA 600:41/01-002/16/17_35)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135
|
HSA 6004101-002-16-17_35 FSN71 KB
|
|
29 Apr 2016
|
AssayTip/AssayCup for MODULAR ANALYTICS E170, MODULAR ANALYTICS EVO E170, cobas e601, cobas e602, Roche Diagnostics GmbH (HSA 600:41/01-016/16/06_20)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: 63716602
|
HSA 6004101-016-16-06_20 FSN357 KB
|
|
28 Apr 2016
|
Digital Diagnost, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/13_37)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 18007445477
|
HSA 6004101-026-16-13_37 FSN226 KB
|
|
27 Apr 2016
|
Philips MX 16-Slice Computed Tomography X-ray System, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/12_45)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 18007445477
|
HSA 6004101-026-16-12_45 FSN448 KB
|
|
27 Apr 2016
|
LYNOAMP BC, Sysmex Corporation (HSA 600:41/01-032/16/04_61)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: Goh.PeiJing@sysmex-ap.com
|
HSA 6004101-032-16-04_61 FSN37 KB
|
|
26 Apr 2016
|
ARCHITECT STAT High Sensitive Troponin-I Reagent, Abbott Ireland (HSA 600:41/01-005/16/06_24)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 68859103
|
HSA 6004101-005-16-06_24 FSN36 KB
|
|
26 Apr 2016
|
Insulin-Like Growth Factor (IGF-1) Assay, Siemens Healthcare Diagnostics Product Limited (HSA 600:41/01-022/16/20_60)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: 64907374
|
HSA 6004101-022-16-20_60 FSN74 KB
|
|
25 Apr 2016
|
Biograph mCT and mCT Flow systems, Biograph TruePoint systems running PETsyngo 6.7.x software, Siemens Medical Solutions USA (HSA 600:41/01-022/16/19_25)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
|
HSA 6004101-022-16-19_25 FSN3622 KB
|
|
25 Apr 2016
|
Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance 64, Brilliance iCT and Brilliance iCT SP CT systems, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/11_19)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 18007445477
|
HSA 6004101-026-16-11_19 FSN 1202 KB
HSA 6004101-026-16-11_19 FSN 2320 KB
|
|
22 Apr 2016
|
Pump Tube, Richard Wolf GmbH (HSA 600:41/01-119/16/01_51)
Local Contact: Servicom Medical (Singapore) Pte Ltd
Contact no./Email: inquiry@servicom.com.sg
|
HSA 6004101-119-16-01_51-FSN274 KB
|
|
22 Apr 2016
|
Digitoxin, Roche Diagnostics GmbH (HSA 600:41/01-016/16/05_59)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
|
HSA 6004101-016-16-05_59 FSN467 KB
|
|
22 Apr 2016
|
Discovery IGS 730 & Discovery IGS 740 systems, GE Medical Systems SCS (HSA 600:41/01-010/16/05_08)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: svc@ge.com
|
HSA 6004101-010-16-05_08 FSN648 KB
|
|
22 Apr 2016
|
Aisys family of Anaesthesia devices, Datex-Ohmeda Inc (HSA 600:41/01-010/16/06_17)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: postmarket@ge.com
|
HSA 6004101-010-16-06_17 FSN73 KB
|
|
22 Apr 2016
|
REVOLUTION CT COMPUTED TOMOGRAPHY X-RAY SYSTEM, GE Healthcare (HSA 600:41/01-010/16/07_18)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: postmarket@ge.com
|
HSA 6004101-010-16-07_18 FSN59 KB
|
|
22 Apr 2016
|
Datascope Cardiosave™ Hybrid Intra-Aortic Balloon Pump (IABP) & Rescue IABP, Datascope Corp (HSA 600:41/01-017/16/02_54)
Local Contact: IDS Medical Systems (Singapore) Pte Ltd
Contact no./Email: 66907378
|
HSA 6004101-017-16-02_54 FSN81 KB
|
|
22 Apr 2016
|
Battery Packs Used in Capnostream 20 and Capnostream 20p Patient Monitors, Medtronic Inc (HSA 600:41/01-046/16/05_48)
Local Contact: Covidien Pte Ltd
Contact no./Email: 64396974
|
HSA 6004101-046-16-05_48 FSN945 KB
|
|
22 Apr 2016
|
Image Suite 3.0 & 4.0, Carestream Health Inc (HSA 600:41/01-187/16/01_09)
Local Contact: Carestream Health Singapore Pte Ltd
Contact no./Email: 65015007
|
HSA 6004101-187-16-01_09 FSN30 KB
|
|
21 Apr 2016
|
Siemens RAPIDPoint® 500 System, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/18_58)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
|
HSA 6004101-022-16-18_58 FSN20 KB
|
|
21 Apr 2016
|
Ellipse™ Implantable Cardioverter Defibrillator, St Jude Medical (HSA 600:41/01-025/16/01_46)
Local Contact: St Jude Medical (S) Pte Ltd
Contact no./Email: 66432817
|
HSA 6004101-025-16-01_46 FSN28 KB
|
|
21 Apr 2016
|
AV-Set ONLINEplus BVM 5008-R, Fresenius Medical Care (HSA 600:41/01-062/16/01_52)
Local Contact: Fresenius Medical Care Singapore Pte Ltd
Contact no./Email: 66813149
|
HSA 6004101-062_16-01_52 FSN2138 KB
|
|
21 Apr 2016
|
Teleflex Medical Pleur-Evac Chest Drainage Systems, Teleflex Medical (HSA 600:41/01-139/16/04_56)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact no./Email: 64393043
|
HSA 6004101-139-16-04_56 FSN444 KB
|
|
20 Apr 2016
|
Alcon LenSx Laser System, Alcon LenSx Inc (HSA 600:41/01-135/16/02_50)
Local Contact: Alcon Pte Ltd
Contact no./Email: vigilance.alconSG@alcon.com
|
HSA 6004101-135-16-02_50 FSN133 KB
|
|
20 Apr 2016
|
ID-Papain, DiaMed GmbH (HSA 600:41/01-027/16/04_57)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 64904262
|
HSA 6004101-027-16-04_57 FSN142 KB
|
|
20 Apr 2016
|
CDI® Blood Parameter Monitoring System 500, BPM Sensor Head Assembly Thermistor, Terumo Cardiovascular Systems (HSA 600:41/01-028/16/03_40)
Local Contact: Terumo Singapore Pte Ltd
Contact no./Email: 62913603
|
HSA 6004101-028-16-03_40 FSN196 KB
|
|
20 Apr 2016
|
Bravo pH Monitoring System, Given Imaging Inc (HSA 600:41/01-046/16/04_36)
Local Contact: Covidien Pte Ltd
Contact no./Email: 64396974
|
HSA 6004101-046-16-04_36 FSN875 KB
|
|
20 Apr 2016
|
Bard Encor Probes, SenoRx Inc (HSA 600:41/01-050/16/04_41)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: 65805987
|
HSA 6004101-050-16-04_41 FSN161 KB
|
|
20 Apr 2016
|
Uni-Gold LUA Plus, Trinity Biotech (HSA 600:41/01-111/16/01_34)
Local Contact: Unison Collaborative Pte Ltd
Contact no./Email: regulatory@unisoncoll.com
|
HSA 6004101-111-16-01_34 FSN2181 KB
|
|
19 Apr 2016
|
Arietta 60 & Arietta 70, Hitachi Aloka Medical Ltd (HSA 600:41/01-054/16/02_33)
Local Contact: Hitachi Medical Systems (S) Pte Ltd
Contact no./Email: 66020110
|
HSA 6004101-054-16-02_33 FSN1642 KB
|
|
19 Apr 2016
|
PENTARAY® NAV Catheters, PENTARAY® NAV eco Catheters, Biosense Webster Inc (HSA 600:41/01-002/16/16_35)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135
|
HSA 6004101-002-16-16_35 FSN100 KB
|
|
19 Apr 2016
|
cobas EGFR Mutation Test v2, Roche Diagnostics GmbH (HSA 600:41/01-016/16/04_31)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
|
HSA 6004101-016-16-04_31 FSN281 KB
|
|
19 Apr 2016
|
MobileDiagnost wDR2, Philips Medical Systems (HSA 600:41/01-026/16/10_37)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 18007445477
|
HSA 6004101-026-16-10_37 FSN128 KB
|
|
19 Apr 2016
|
Leksell Gamma Knife® Perfexion™, Elekta Instrument AB (HSA 600:41/01-101/16/01_45)
Local Contact: Elekta Pte Ltd
Contact no./Email: elekta_global_pms@elekta.com
|
HSA 6004101-101-16-01_45 FSN87 KB
|
|
18 Apr 2016
|
BENDING/CUTTING PLIERS WITH NOSE, FOR LOCK PLATES 2.0, Synthes GmbH (HSA 600:41/01-002/16/14_19)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135
|
HSA 6004101-002-16-14_19 FSN77 KB
|
|
18 Apr 2016
|
CIDEX Activated Glutaraldehyde Solution, Advanced Sterilization Products (HSA 600:41/01-002/16/15_54)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 68276135
|
HSA 6004101-002-16-15_54 FSN274 KB
|
|
15 Apr 2016
|
UniCel Coulter Cellular Analysis System - DxH 800, DxH 600, DxH Slidemaker Stainer, Beckman Coulter Inc. (HSA 600:41/01-052/16/03_22)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 6340 7126
|
HSA 6004101-052-16-03_22 FSN73 KB
|
|
15 Apr 2016
|
IRISpec CA/CB/CC, Iris International (HSA 600:41/01-052/16/04_23)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 6340 7126
|
HSA 6004101-052-16-04_23 FSN171 KB
|
|
15 Apr 2016
|
Access ClearVue™ Prone Breast device, Qfix (HSA 600:41/01-227/16/01_18)
Local Contact: QT Instruments (S) Pte Ltd
Contact no./Email: 6303 9833
|
HSA 6004101-227-16-01_18 FSN494 KB
|
|
14 Apr 2016
|
da Vinci S Surgical System / da Vinci Si Surgical System / da Vinci Xi Surgical System, Intuitive Surgical (HSA 600:41/01-070/16/10_08)
Local Contact: Transmedic Pte Ltd
Contact no./Email: regulatory@transmedicgroup.com
|
HSA 6004101-070-16-10_08 FSN403 KB
|
|
14 Apr 2016
|
Integra 3 Micromanipulator, Research Instruments Limited (HSA 600:41/01-210/16/01_17)
Local Contact: LabIVF Asia Pte Ltd
Contact no./Email: sales@labivf.com
|
HSA 6004101-210-16-01_17 FSN3356 KB
|
|
14 Apr 2016
|
3.5mm Locking Screws - Stardrive®, Self·Tapping & Hex Drive, Self·Tapping, Synthes GmbH (HSA 600:41/01-002/16/13_09)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6827 6135
|
HSA 6004101-002-16-13_09 FSN80 KB
|
|
12 Apr 2016
|
Baxter Colleague CXE Volumetric Infusion Pump, Baxter Healthcare SA (HSA 600:41/01-001/16/02_46)
Local Contact: Baxter Healthcare (Asia) Pte Ltd Contact no./Email: chai_hwee_corynn_tan@baxter.com
|
HSA 6004101-001-16-02_46 FSN338 KB
|
|
12 Apr 2016
|
Lotus Valve System, Boston Scientific (HSA 600:41/01-007/16/02_48)
Local Contact: Boston Scientific Asia Pacific Pte. Ltd.
Contact no./Email: 6418 8888
|
HSA 6004101-007-16-02_48 FSN632 KB
|
|
12 Apr 2016
|
Hickman and Leonard Central Venous Catheter kits, Bard Access Systems, Inc. (HSA 600:41/01-050/16/03_56)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: 6580 5988
|
HSA 6004101-050-16-03_56 FSN1259 KB
|
|
11 Apr 2016
|
VITROS® 3600 Immunodiagnostics System & VITROS® 5600 Integrated System, Ortho-Clinical Diagnostic Inc (HSA 600:41/01-002/16/12_20)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6827 6079
|
HSA 6004101-002-16-12_20 FSN131 KB
|
|
08 Apr 2016
|
Ossur Lil’ Angel Halo Vest, Ossur hf (HSA 600:41/01-053/16/02_43)
Local Contact: Humedical Pte Ltd
Contact no./Email: gerwin@humedical.com.sg
|
HSA 6004101-053-16-02_43 FSN100 KB
|
|
08 Apr 2016
|
Miami J Cervical Collars, Ossur hf (HSA 600:41/01-053/16/01_52)
Local Contact: Humedical Pte Ltd
Contact no./Email: 6872 1738
|
HSA 6004101-053-16-01_52 FSN333 KB
|
|
08 Apr 2016
|
BIRMINGHAM HIP™ RESURFACING Extraction Kit (instrument), Smith & Nephew Orthopaedics (HSA 600:41/01-073/16/12_50)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: 6672 5446
|
HSA 6004101-073-16-12_50 FSN70 KB
|
|
07 Apr 2016
|
CA090 Direct Drive Clip Applier, Applied Medical (HSA 600:41/01-163/16/02_41)
Local Contact: Ikon Medical Pte Ltd
Contact no./Email: 6336 5813
|
HSA 6004101-163-16-02_41 FSN115 KB
|
|
06 Apr 2016
|
Ossur Miami J Cervical Collars, Ossur hf (HSA 600:41/01-294/16/02_40)
Local Contact: Ossur JWC Holding Pte Ltd
Contact no./Email: enquiries@ossur.com
|
HSA 6004101-294-16-02_40 FSN829 KB
|
|
06 Apr 2016
|
Draeger D-Vapor and D-Vapor 3000, Draeger Medical South East Asia Pte Ltd (HSA 600:41/01-063/16/01_36)
Local Contact: Draeger Medical SEA Pte Ltd
Contact no./Email: dsa.singapore@draeger.com
|
HSA 6004101-063-16-01_36 FSN8985 KB
|
|
06 Apr 2016
|
Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage & Cartilage Custom, Rebound Air Walker & Diabetic Walker, Back Support Suspenders, Extreme Custom, Unloader Custom (XT & Lite) & Custom, Ossur hf (HSA 600:41/01-294/16/01_45)
Local Contact: Ossur JWC Holding Pte Ltd
Contact no./Email: enquiries@ossur.com
|
HSA 6004101-294-16-01_45 FSN829 KB
|
|
05 Apr 2016
|
Essure ® ESS-305, Bayer Healthcare LLC (HSA 600:41/01-066/16/01_49)
Local Contact: Bayer South East Asia Pte Ltd
Contact no./Email: medinfo.singapore@bayer.com
|
HSA 6004101-066-16-01_49 FSN37 KB
|
|
04 Apr 2016
|
LifeCycle for Prenatal Screening, Wallac Oy (HSA 600:41/01-127/16/01_59)
Local Contact: Perkin Elmer Singapore Pte Ltd
Contact no./Email: 68681670
|
HSA 6004101-127-16-01_59 FSN1823 KB
|
|
01 Apr 2016
|
Philips IntelliSpace Portal software versions 5.0, 6.0, 7.0, Philips Medical Systems Nederland BV (HSA 600:41/01-026/16/08_37)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5466
|
HSA 6004101-026-16-08_37 FSN59 KB
|
|
01 Apr 2016
|
Acuson SC2000, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/16/16_44)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
|
HSA 6004101-022-16-16_44 FSN1115 KB
|
|
01 Apr 2016
|
SOMATOM Definition FORCE with VA50A, VA50A_SP2, Siemens Healthcare GmbH (HSA 600:41/01-022/16/15_29)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
|
HSA 6004101-022-16-15-29 FSN1783 KB
|
|
01 Apr 2016
|
Acuson SC2000, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/16/17_33)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
|
HSA 6004101-022-16-17_33 FSN_Redacted1078 KB
|