Date of Notification | Title | FSN |
|---|
31 Mar 2017 | Synthes MatrixMIDFACE, Synthes MatrixMandible, Synthes MatrixORTHOGNATHIC and Synthes MatrixNEURO, Synthes GmbH (HSA 600:41/01-002/17/06_45)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6750 4213 | HSA 6004101-002-17-06_45 FSN [PDF, 199 KB] |
30 Mar 2017 | Monolisa HCV Ag-Ab ULTRA V2 Assay, Bio-Rad France (HSA 600:41/01-027/17-04_34)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262 | HSA 6004101-027-17-04_34 FSN_Redacted [PDF, 232 KB] |
27 Mar 2017 | Draeger Infinity Delta Series, Draeger Medical Systems, Inc (HSA 600:41/01-063/17/01_33)
Local Contact: Draeger Singapore Pte Ltd
Contact no./Email: 6872 9288 / draeger.sg@draeger.com | HSA 6004101-063-17-01_33 FSN_Redacted [PDF, 2171 KB] |
27 Mar 2017 | CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems, GE Medical Systems SC S (HSA 600:41/01-010/17/02_63)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com | HSA 6004101-010-17-02_63 FSN_Redacted [PDF, 446 KB] |
24 Mar 2017 | Acufex Trunav Retrograde Drills, Smith & Nephew Inc (HSA 600:41/01-073/17/06_25)
Local Contact:Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-17-06_25 FSN [PDF, 213 KB] |
23 Mar 2017 | Vivid E95/E90/E80/S70/S60/S70N/S60N Ultrasound System, GE Vingmed Ultrasound AS; GE Medical Systems Israel (HSA 600:41/01-010/17/01_25)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com | HSA 6004101-010-17-01_25 FSN_Redacted [PDF, 124 KB] |
23 Mar 2017 | DA VINCI® SI AND XI SURGEON SIDE CONSOLE CIRCUIT BOARD, Intuitive Surgical, Inc (HSA 600:41/01-070/17/06_44)
Local Contact:Transmedic Pte Ltd
Contact no./Email:6477 6101 / regulatory@transmedicgroup.com | HSA 6004101-070-17-06_44 FSN [PDF, 369 KB] |
23 Mar 2017 | Zenith Alpha Thoracic Endovascular Graft, William Cook Europe Aps (HSA 600:41/01-013/17/01_64)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6812 7400 / SNG-RegulatoryAffairs@cookmedical.com | HSA 6004101-013-17-01_64 FSN_Redacted [PDF, 216 KB] |
22 Mar 2017 | da Vinci Xi EndoWrist Stapler Release Kit, Intuitive Surgical (HSA 600:41/01-070/17/05_52)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com | HSA 6004101-070-17-05_ [PDF, 589 KB] |
22 Mar 2017 | BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/17/06_31)
Local Contact: Becton Dickinson Holdings Pte. Ltd. (BD)
Contact no./Email: 6432 2048 | HSA 6004101-003-17-06_31 FSN_Redacted [PDF, 116 KB] |
21 Mar 2017 | NC Trek RX Coronary Dilatation Catheter, Abbott Vascular (HSA 600:41/01-005/17/03_46)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: 6270 0760 / FSN_Inquiry@abbott.com | HSA 6004101-005-17-03_46 FSN_Redacted [PDF, 255 KB] |
21 Mar 2017 | Alaris™ LVP (Large Volume Pump) Module 8100, CareFusion 303 Inc (HSA 600:41/01-003/17/05_56)
Local Contact: Becton Dickinson Holdings Pte. Ltd. (BD)
Contact no./Email: 6432 2048 | HSA 6004101-003-17-05_56 FSN_Redacted [PDF, 368 KB] |
21 Mar 2017 | SmartSite Add‐On Bag Access Device, CareFusion 303 Inc (HSA 600:41/01-003/17/06_48)
Local Contact: Becton Dickinson Holdings Pte. Ltd. (BD)
Contact no./Email: 6432 2048 | HSA 6004101-003-17-06_48 FSN_Redacted [PDF, 3130 KB] |
21 Mar 2017 | Screwdriver Shaft, hexagonal, large, ⌀ 3.5 mm, length 165mm, for Quick Coupling, Synthes GmbH (HSA 600:41/01-002/17/05_48)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6750 4213 | HSA 6004101-002-17-05_48 FSN_Redacted [PDF, 1622 KB] |
20 Mar 2017 | Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, 35mm, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/17/04_54)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6750 4213 | HSA 6004101-002-17-04_54 FSN [PDF, 723 KB] |
17 Mar 2017 | DBS LEAD DEPTH STOP FOR MEDTRONIC DBS LEAD KIT FOR STIMULATION OF THE BRAIN, Medtronic Inc. (HSA 600:41/01-009/17/05_19)
Local Contact: Medtronic International Ltd.
Contact no./Email:6439 6932 | HSA 6004101-009-17-05_19 FSN_Redacted [PDF, 3299 KB] |
17 Mar 2017 | EOS™ X-Ray Imaging Acquisition System, EOS Imaging (HSA 600:41/01-238/17/01_63)
Local Contact: QST Technologies Pte Ltd
Contact no./Email: 6270 6260 | HSA 6004101-238-17-01_63 FSN_Redacted [PDF, 91 KB] |
15 Mar 2017 | Philips Allura Xper X-ray Systems, Philips Medical Systems Netherland BV (HSA 600:41/01-026/17/06_41)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477 | HSA 6004101-026-17-06_41 FSN_Redacted [PDF, 386 KB] |
15 Mar 2017 | VITEK MS V2.0 clinical and VITEK MS V3.0 clinical, bioMerieux SA (HSA 600:41/01-146/17/03_67)
Local Contact: BioMerieux Singapore Pte Ltd
Contact no./Email: ruhil.apashvinkumar@ext.biomerieux.com | HSA 6004101-146-17-03_67 FSN [PDF, 66 KB] |
15 Mar 2017 | ReNu® Fresh™ Multi-purpose Solution, Bausch & Lomb, Incorporated (HSA 600:41/01-030/17/02_50)
Local Contact: Bausch & Lomb (Singapore) Pte. Ltd.
Contact no./Email: 6834 9112 | HSA 6004101-030-17-02_50 FSN [PDF, 394 KB] |
14 Mar 2017 | Stryker SmartLife Large Aseptic Housing, Stryker Instruments (HSA 600:41/01-014/17/01_40)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com | HSA 6004101-014-17-01_40 FSN [PDF, 160 KB] |
14 Mar 2017 | Ortho-Clinical Diagnostics Biovue® System ABO-Rh/Reverse Grouping Cassette, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/17/06_65)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email:6486 1151 | HSA 6004101-303-17-06_65 FSN_Redacted [PDF, 1897 KB] |
13 Mar 2017 | Proteus 235 Proton Therapy System, Ion Beam Applications S.A. (HSA 600:41/01-070/17/04_51)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com | HSA 6004101-070-17-04_51 FSN_Redacted [PDF, 78 KB] |
10 Mar 2017 | PHILIPS INTELLIVUE MX40 WLAN PATIENT WEARABLE MONITOR, Philips Medical Systems (HSA 600:41/01-026/17/05_44)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477 | HSA 6004101-026-17-05_44 FSN_Redacted [PDF, 149 KB] |
10 Mar 2017 | Sample probes, Roche Diagnostics GmbH (HSA 600:41/01-016/17/06_61)
Local Contact:Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email:sg.regulatory@roche.com | HSA 6004101-016-17-06_61 FSN [PDF, 3241 KB] |
10 Mar 2017 | VITROS Immunodiagnostic Products NT-proBNP Reagent Pack, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/17/05_31)
Local Contact:Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email:6486 1151 | HSA 6004101-303-17-05_31 FSN_Redacted [PDF, 161 KB] |
09 Mar 2017 | EliA Sample Diluent, Phadia AB (HSA 600:41/01-033/17/01_59)
Local Contact: Biomed Diagnostics Pte Ltd
Contact no./Email: 6298 4347 / biomed.regulatory@biomed-global.com |
|
07 Mar 2017 | Manometer Tray, Carefusion/BD (HSA 600:41/01-145/17/01_35)
Local Contact: Medquest Marketing Pte Ltd
Contact no./Email:6805 1260 | HSA 6004101-145-17-01_35 FSN_Redacted [PDF, 1911 KB] |
06 Mar 2017 | Medtronic StrataMR™ Adjustable Valves & Shunts, Medtronic Inc. (HSA 600:41/01-009/17/04_64)
Local Contact:Medtronic International Ltd
Contact no./Email:6439 6932 | HSA 6004101-009-17-04_64 FSN_Redacted [PDF, 6359 KB] |
06 Mar 2017 | Beckman Coulter IMMAGE Immunochemistry Systems Cuvette Sectors, Beckman Coulter Inc (HSA 600:41/01-052/17/02_58)
Local Contact:Beckman Coulter Singapore Pte Ltd
Contact no./Email:6340 7126 | HSA 6004101-052-17-02_58 FSN_Redacted [PDF, 144 KB] |
03 Mar 2017 | Bausch & Lomb Laseredge Knife, Bausch & Lomb Incorporated (HSA 600:41/01-030/17/01_37)
Local Contact: Bausch & Lomb (Singapore) Pte Ltd
Contact no./Email: 6834 9112 | HSA 6004101-030-17-01_37 FSN_Redacted [PDF, 345 KB] |
03 Mar 2017 | cobas e602 and cobas e801, Roche Diagnostics GmbH (HSA 600:41/01-016/17/05_57)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email:sg.regulatory@roche.com | HSA 6004101-016-17-05_57 FSN [PDF, 343 KB] |
03 Mar 2017 | Philips Brightview Imaging System, Philps Brightview XCT Imaging System, Philips Medical Systems Inc (HSA 600:41/01-026/17/04_64)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477 | HSA 6004101-026-17-04_64 FSN_Redacted [PDF, 163 KB] |
03 Mar 2017 | Cobas® 8100 BRF and URF, Roche Diagnostics GmbH (HSA 600:41/01-016/17/04_38)
Local Contact:Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email:sg.regulatory@roche.com | HSA 6004101-016-17-04_38 FSN [PDF, 160 KB] |
03 Mar 2017 | Covidien Curity Eye Pad, Covidien Curity Eye Pad Oval, Covidien Curity Eye Pad, Covidien Curity Wet Dressing, Covidien Kerlix Super Sponge Saline Dressing, Covidien Curity Sodium Chloride Dressing, Covidien Curity Saline Dressing, Covidien LLC (HSA 600:41/01-046/17/02_33)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6974 | HSA 6004101-046-17-02_33 FSN_Redacted [PDF, 1928 KB] |
02 Mar 2017 | DYONICS BATTERY POWER HAND PIECES, Smith & Nephew Inc. (HSA 600:41/01-073/17/05_19)
Local Contact: Smith & Nephew Pte Limited
Contact no./Email: singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-17-05_19 FSN_Redacted [PDF, 75 KB] |
02 Mar 2017 | Disposable Kits for patient positioning, Smith & Nephew Inc. (HSA 600:41/01-073/17/06_45)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-17-06_45 FSN [PDF, 105 KB] |
01 Mar 2017 | Philips HeartStart MRx Monitor/Defibrillator, Philips Medical Systems (HSA 600:41/01-026/17/03_18)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477 | HSA 6004101-026-17-03_18 FSN_Redacted [PDF, 92 KB] |
01 Mar 2017 | Biomet Orthopedics Vanguard® Complete Knee System, Biomet Orthopedics (HSA 600:41/01-008/17-03_43)
Local Contact:Zimmer Pte Ltd
Contact no./Email:6854 7222 / cs.singapore@zimmerbiomet.com | HSA 6004101-008-17-03_43 FSN _Redacted [PDF, 668 KB] |
01 Mar 2017 | iASSIST Validation Tool, Zimmer CAS (HSA 600:41/01-008/17/02_52)
Local Contact:Zimmer Pte Ltd
Contact no./Email:6854 7222 / cs.singapore@zimmerbiomet.com | HSA 6004101-008-17-02_52 FSN_Redacted [PDF, 592 KB] |
01 Mar 2017 | GanglioCombi MAG Elisa, Buhlmann Laboratories AG (HSA 600:41/01-137/17/03_34)
Local Contact: All Eights (Singapore) Pte Ltd
Contact no./Email: 6288 6388 / alleight@alleight.com | HSA 6004101-137-17-03_34 FSN_Redacted [PDF, 162 KB] |
