Date of Notification | Title | FSN |
|---|
28 Feb 2017 | Abbott Cell-Dyn Ruby, Abbott Laboratories (HSA 600:41/01-005/17/02_61)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: FSN@enquiry@abbott.com | HSA 6004101-005-17-02_61 FSN [PDF, 97 KB] |
28 Feb 2017 | Philips Brilliance Computed Tomography X-Ray System, Philips Medical Systems Inc (HSA 600:41/01-026/17/02_40)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477 | HSA 6004101-026-17-02_40 FSN_Redacted [PDF, 215 KB] |
27 Feb 2017 | BUHLMANN CALEX CAP, Buhlmann Laboratories AG (HSA 600:41/01-137/17/02_65)
Local Contact: All Eights (Singapore) Pte Ltd
Contact no./Email: 6288 6388 / alleight@alleight.com | HSA 6004101-137_17-02_65 FSN_Redacted [PDF, 3008 KB] |
27 Feb 2017 | CT Asphina 409MP, Carl Zeiss Meditec Ag (HSA 600:41/01-136/17/02_49)
Local Contact: Carl Zeiss Pte Ltd
Contact no./Email: info@zeiss.com.sg | HSA 6004101-136-17-02_49 FSN_Redacted [PDF, 79 KB] |
27 Feb 2017 | Gambro Prismaflex Haemodialysis Control Unit, Gambro Lundia AB (HSA 600:41/01-001/17/01_48)
Local Contact: Baxter Healthcare (Asia) Pte. Ltd.
Contact no./Email: 6826 2616 | HSA 6004101-001-17-01_48 FSN_Redacted [PDF, 719 KB] |
24 Feb 2017 | Endurant/ Endurant II Bifurcated Stent Graft Systems, Medtronic Inc (HSA 600:41/01-009/17/03_56)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5000 / dl.sgreg@medtronic.com | HSA 6004101-009-17-03_56 FSN_Redacted [PDF, 170 KB] |
24 Feb 2017 | Boston Scientific Lotus Valve System and Accessories, Boston Scientific Corporation (HSA 600:41/01-007/17/02_46)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: Singapore_ FSCA _ Query@bsci.com | HSA 6004101-007-17-02_46 FSN_Redacted [PDF, 1727 KB] |
24 Feb 2017 | Ortho Clinical VITROS Chemistry Products VANC Reagent, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/17/04_58)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 6486 1151 | HSA 60041-01-303-17-04_58 FSN_Redacted [PDF, 539 KB] |
23 Feb 2017 | CORDIS SMART FLEX VASCULAR STENT SYSTEM, Cordis Cashel (HSA 600:41/01-307/17/01_54)
Local Contact: CARDINAL HEALTH SINGAPORE 225 PTE. LTD.
Fax: 6230 2360 | HSA 6004101-307-17-01_54 FSN_Redacted [PDF, 205 KB] |
22 Feb 2017 | Liquichek Diabetes Control, Bio-Rad Laboratories (HSA 600:41/01-027/17/03_61)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262 | HSA 6004101-027-17-03_61 FSN [PDF, 95 KB] |
22 Feb 2017 | Siemens Artis systems, Siemens Healthcare GmbH (HSA 600:41/01-022/17/11_43)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com | HSA 6004101-022-17-11_43 FSN_Redacted [PDF, 2807 KB] |
22 Feb 2017 |
Olympus ENDOEYE HD II Video Telescope, Olympus Winter & Ibe GmbH (HSA 600:41/01-004/17/01_52)
Local Contact:Olympus Singapore Pte Ltd.
Contact no./Email:mes-ra.osp@olympus-ap.com
| HSA 6004101-004-17-01_52 FSN_Redacted [PDF, 544 KB] |
21 Feb 2017 | Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/17/10_51)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com | HSA 6004101-022-17-10_51 FSN_Redacted [PDF, 2780 KB] |
20 Feb 2017 |
ADVIA 560 Hematology System, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/17/09_59)
Local Contact:Siemens Healthcare Pte Ltd
Contact no./Email:ui-handling.sg@siemens.com
| HSA 6004101-022-17-09_59 FSN [PDF, 77 KB] |
15 Feb 2017 |
Respironics V60 Ventilator, Respironics California Inc. (HSA 600:41/01-026/17/01_19)
Local Contact:Philips Electronics (S) Pte Ltd
Contact no./Email:1800 744 5477
| HSA 6004101-026-17-01_19 FSN [PDF, 243 KB] |
15 Feb 2017 |
ADVIA Chemistry LDLP and LDPL, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/17/08_59)
Local Contact:Siemens Healthcare Pte Ltd
Contact no./Email:ui-handling.sg@siemens.com
| HSA 6004101-022-17-08_59 FSN [PDF, 88 KB] |
15 Feb 2017 |
Bio-Rad DiaMed ID-Card LISS/Coombs, DiaMed GmbH (HSA 600:41/01-027/17/02_60)
Local Contact:Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email:6490 4262
| HSA 6004101-027-17-02_60 FSN Part 2_Redacted [PDF, 3256 KB] HSA 6004101-027-17-02_60 FSN_Redacted [PDF, 1236 KB] |
14 Feb 2017 |
Proteus 235 Proton Therapy System, Ion Beam Applications S.A. (HSA 600:41/01-070/17/03_56)
Local Contact:Transmedic Pte Ltd
Contact no./Email:regulatory@transmedicgroup.com
| HSA 6004101-070-17-03_56 FSN [PDF, 344 KB] |
13 Feb 2017 |
Hoya Pentax Video Endoscopes System, Hoya Corporation (HSA 600:41/01-106/17/03_50)
Local Contact:Pentax Medical Singapore Pte Ltd
Contact no./Email:vigilanceAsia@pentaxmedical.com
| HSA 6004101-106-17-03_50 FSN_Redacted [PDF, 504 KB] |
10 Feb 2017 | VisuMax Laser Keratome, Carl Zeiss Meditec AG (HSA 600:41/01-136/17/01_40)
Local Contact:Carl Zeiss Pte Ltd
Contact no./Email:info@zeiss.com.sg | HSA 6004101-136-17-01_40 FSN_Redacted [PDF, 908 KB] |
10 Feb 2017 |
VITROS Chemistry Products PHYT Slides, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/17/03_58)
Local Contact:Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email:6486 1151
| HSA 6004101-303-17-03_58 FSN_Redacted [PDF, 960 KB] |
10 Feb 2017 |
OF-BI13 (IRRIGATION TUBE), OE-B5 (INJECTION TUBE), HOYA Corporation (HSA 600:41/01-106/17/02_41)
Local Contact:Pentax Medical Singapore Pte. Ltd.
Contact no./Email:vigilanceAsia@pentaxmedical.com
| HSA 6004101-106-17-02_41 FSN_Redacted [PDF, 385 KB] |
10 Feb 2017 |
OS4 Surgery System with Endolaser, Oertli Instrumente AG (HSA 600:41/01-110/17/01_45)
Local Contact:Mandarin Opto-Medic Co Pte Ltd
Contact no./Email:6747 8777
| HSA 6004101-110-17-01_45 FSN_Redacted [PDF, 3475 KB] |
10 Feb 2017 |
Physio-Control LIFEPAK® 15 Defibrillator Monitor System, Physio-Control, Inc (HSA 600:41/01-056/17/04_54)
Local Contact:Gold Lite Pte Ltd
Contact no./Email:6273 0487
| HSA 6004101-056-17-04_54 FSN_Redacted [PDF, 41 KB] |
09 Feb 2017 | GENTAMICIN, Roche Diagnostics GmbH (HSA 600:41/01-016/16/08_59)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email:sg.regulatory@roche.com | HSA 6004101-016-16-08_59 FSN (Updated) [PDF, 216 KB] |
09 Feb 2017 |
Roche Diagnostics Elecsys® Anti-HAV, Roche Diagnostics GmbH (HSA 600:41/01-016/17/03_57)
Local Contact:Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email:sg.regulatory@roche.com
| HSA 6004101-016-17-03_57 FSN [PDF, 352 KB] |
09 Feb 2017 |
LifePack 1000 Defibrillator, Physio-Control, Inc (HSA 600:41/01-056/17/03_37)
Local Contact:Gold Lite Pte Ltd
Contact no./Email:6273 0487
| HSA 6004101-056-17-03_37 FSN_Redacted [PDF, 511 KB] |
09 Feb 2017 |
Medtronic Strata™ II / Strata™ NSC valves (includes Burr Hole and Lumboperitoneal. Excludes StrataMR™), Medtronic Inc (HSA 600:41/01-009/17/02_44)
Local Contact:Medtronic International Limited
Contact no./Email:6439 6932
| HSA 6004101-009-17-02_44 FSN_Redacted [PDF, 1445 KB] |
09 Feb 2017 | BD Plastipak™ 100mL Syringe, Catheter tip with Luer slip adaptor, Becton, Dickinson and Company Limited (BD) (HSA 600:41/01-003/17/04_35)
Local Contact: Becton Dickinson Holdings Pte Ltd (BD)
Contact no./Email: 6432 2048 | HSA 6004101-003-17-04_35 FSN Part 1_Redacted [PDF, 64 KB] |
09 Feb 2017 |
VITROS Chemistry Products Li Slides, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/17/02_38)
Local Contact:Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email:6486 1151
| HSA 6004101-303-17-02_38 FSN_Redacted [PDF, 1683 KB] |
08 Feb 2017 |
Artis systems with software versions VC14, VC21, VD10, VD11 and VE10, Siemens Healthcare GmbH (HSA 600:41/01-022/17/07_19)
Local Contact:Siemens Healthcare Pte Ltd
Contact no./Email:ui-handling.sg@siemens.com
| HSA 6004101-022-17-07_19 FSN_Redacted [PDF, 107 KB] |
08 Feb 2017 |
StarClose SE Vascular Closure System, Abbott Vasscular (HSA 600:41/01-005/17/01_45)
Local Contact:Abbott Laboratories (S) Pte Ltd
Contact no./Email:FSN_Inquiry@abbott.com
| HSA 6004101-005-17-01_45 FSN_Redacted [PDF, 252 KB] |
07 Feb 2017 |
Roche Diagnostics cobas® 4800 HIV-1 Test & Roche Diagnostics cobas®HBV Test, Roche Diagnostics GmbH (HSA 600:41/01-016/17/02_38)
Local Contact:Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email:sg.regulatory@roche.com
| HSA 6004101-016-17-02_38_FSN [PDF, 322 KB] |
06 Feb 2017 |
MiniMedTM 640G Insulin Infusion Pump, Medtronic MiniMed (HSA 600:41/01-009/17/01_18)
Local Contact:Medtronic International Limited
Contact no./Email:6436 5000
| HSA 6004101-009-17-01_18 FSN [PDF, 61 KB] |
06 Feb 2017 |
iChemVELOCITY AUTOMATED URINE CHEMISTRY SYSTEMS, Iris Diagnostics (HSA 600:41/01-052/17/01_34)
Local Contact:Beckman Coulter Singapore Pte Ltd
Contact no./Email:6340 7126
| HSA 6004101-052-17-01_34 FSN_Redacted [PDF, 42 KB] |
06 Feb 2017 |
ValleyLab Laparoscopic Handset, Four-Function, Covidien llc (HSA 600:41/01-046/17/01_25)
Local Contact:Covidien Pte Ltd
Contact no./Email:6439 6974
| HSA 6004101-046-17-01_25 FSN_Redacted [PDF, 1792 KB] |
06 Feb 2017 |
ADVIA Centaur XPT System, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/17/06_31)
Local Contact:Siemens Healthcare Pte Ltd
Contact no./Email:ui-handling.sg@siemens.com
| HSA 6004101-022-17-06_31 FSN [PDF, 88 KB] |
03 Feb 2017 |
Smith & Nephew OSTEORAPTOR™ Suture Anchor, Smith & Nephew Inc. (HSA 600:41/01-073/17/04_17)
Local Contact:Smith & Nephew Pte Ltd
Contact no./Email:singapore.surgicalsale@smith-nephew.com
| HSA 6004101-073-17-04_17 FSN [PDF, 59 KB] |
02 Feb 2017 |
AngioJet Ultra 5000A Console - Foot Switch, Boston Scientific Corporation (HSA 600:41/01-070/17/02_08)
Local Contact:Transmedic Pte Ltd
Contact no./Email:regulatory@transmedicgroup.com
| HSA 6004101-070-17-02_08_FSN [PDF, 23 KB] |
02 Feb 2017 |
LEGION CRUCIATE RETAINING NARROW Femoral Component SZ 5 RT, Smith & Nephew Inc. (HSA 600:41/01-073/17/03_64)
Local Contact:Smith & Nephew Pte Limited
Contact no./Email:singapore.surgicalsale@smith-nephew.com
| HSA 6004101-073-17-03_64 FSN [PDF, 75 KB] |
02 Feb 2017 |
ETEST® XM256 (Cefuroxime), bioMérieux SA (HSA 600:41/01-146/17/02_23)
Local Contact:Biomerieux Singapore Pte Ltd
Contact no./Email:6734 1701
| HSA 6004101-146-17-02_23 FSN [PDF, 438 KB] |
02 Feb 2017 |
Brainlab Offset Cup Impactor Universal, BrainLab AG (HSA 600:41/01-047/17/01_09)
Local Contact:BrainLab Limited (Singapore Branch)
Contact no./Email:6734 1701
| HSA 6004101-047-17-01_09 FSN_Redacted [PDF, 144 KB] |
01 Feb 2017 |
ARTISTE™, ONCOR™ and PRIMUS™ Digital Linear Accelerators, Siemens Healthcare GmbH (HSA 600:41/01-022/17/04_48)
Local Contact:Siemens Healthcare Pte Ltd
Contact no./Email:ui-handling.sg@siemens.com
| HSA 6004101-022-17-04_48 FSN [PDF, 20 KB] |
01 Feb 2017 | Xcela PICC With PASV Valve, Navilyst Medical (HSA 600:41/01-057/17/02_56)
Local Contact:Somnotec (s) Pte Ltd
Contact no./Email:6844 0002 | HSA 6004101-057-17-02_56 FSN_Redacted [PDF, 363 KB] |
01 Feb 2017 |
IMMULITE 2000/IMMULITE 2000 XPi SHBG, Siemens Healthcare Diagnostics Products Limited (HSA 600:41/01-022/17/05_22)
Local Contact:Siemens Healthcare Pte Ltd
Contact no./Email:ui-handling.sg@siemens.com
| HSA 6004101-022-17-05_22 FSN [PDF, 83 KB] |
08 Mar 2016 | Analyst MD Software - Component of API 3200MD LC/MS/MS System, 3200MD QTRAP LC/MS/MS System, Triple Quad 4500MD LC/MS/MS System, and QTRAP 4500MD LC/MS/MS System, AB SCIEX Pte Ltd (HSA 600:41/01-255/16/01_24)
Local Contact:AB SCIEX Pte Ltd
Contact no./Email:6304 3722 | HSA 6004101-255-16-01_24 FSN_Redacted [PDF, 682 KB] |
04 Mar 2014 |
Medtronic SynchroMed® II Programmable Pump System and Accessories, Medtronic Inc (HSA 600:41/01-009/14/04_09)
Local Contact:Medtronic International Limited
Contact no./Email:6436 5000
|
HSA 6004101-009-14-04_09 FSN_Redacted [PDF, 1532 KB] |
28 May 2013 | Medtronic Synchromed® II Programmable Drug Infusion System,Medtronic Inc (HSA 600:41/01-009/13/12_02)
Local Contact:Medtronic International Limited
Contact no./Email:6439 6849 |
HSA 6004101-009-13-12_02 FSN_Redacted [PDF, 1877 KB] |
