Date of Notification | Title | FSN |
|---|
30 Jun 2016 | TWINFIX QUICK-T KNOT PUSHER SUTURE CUTTERS, Smith & Nephew Inc (HSA 600:41/01-073/16/17_40) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-16-17_40 FSN [PDF, 123 KB] |
30 Jun 2016 | LEGION HK 11,12,13MM BOLT AND SLEEVE, Smith & Nephew Inc (HSA 600:41/01-073/16/16_36) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-16-16_36 FSN [PDF, 137 KB] |
29 Jun 2016 | iGuide 2.1.0 and iGuide 2.2.0, Medical Intelligence Medizintechnik GmbH (HSA 600:41/01-101/16/03_37) Local Contact: Elekta Pte Ltd Contact no./Email: 62212322 | HSA 6004101-101-16-03_37 FSN [PDF, 39 KB] |
29 Jun 2016 | Rocket® R51551 Thoracentesis Catheter, Rocket Medical PLC (HSA 600:41/01-057/16/03_49) Local Contact: Somnotec (S) Pte Ltd Contact no./Email: info@somnotec.net | HSA 6004101-057-16-03_49 FSN [PDF, 38 KB] |
29 Jun 2016 | 3M PICC/CVC Securement Device + Tegaderm I.V. Advanced Securement Dressing, 3M Health Care (HSA 600:41/01-031/16/01_35) Local Contact: 3M Technologies (S) Pte Ltd Contact no./Email: 64508846 | HSA 6004101-031-16-01_35 FSN [PDF, 84 KB] |
29 Jun 2016 | ADVIA Chemistry Theophylline_2 Reagent, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/30_57) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: 64907374 | HSA 6004101-022-16-30_57 FSN [PDF, 122 KB] |
29 Jun 2016 | Triathlon Modular Handle, Howmedica Osteonics Corp aka Stryker Orthopedics (HSA 600:41/01-014/16/08_33) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: ASEAN.PMS@stryker.com
| HSA 6004101-014-16-08_33 FSN [PDF, 88 KB] |
29 Jun 2016 | Synovis Vascu-Guard Peripheral Vascular Patch, Synovis Surgical Innovations (HSA 600:41/01-001/16/04_45) Local Contact: Baxter Healthcare(Asia)Pte Ltd Contact no./Email: 68262616 | HSA 6004101-001-16-04_45 FSN [PDF, 259 KB] |
28 Jun 2016 | AIRVO 2 and myAIRVO 2, Fisher & Paykel Healthcare Limited (HSA 600:41/01-263/16/05_09) Local Contact: Emergo Singapore Consulting Pte Ltd Contact no./Email: 68325625 | HSA 6004101-263-16-05_09 FSN [PDF, 47 KB] |
28 Jun 2016 | Allura Xper R8.2, UNIQ R1.0 X-ray Systems, Philips Medical Systems Nederland BV (HSA 600:41/01-026/16/25_18) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 18007445477 | HSA 6004101-026-16-25_18 FSN [PDF, 287 KB] |
28 Jun 2016 | API 3200MD LC/MS/MS system, 3200MD Qtrap LC/MS/MS system, Triple Quad 4500MD LC/MS/MS system and Qtrap LC/MS/MS system, AB SCIEX Pte Ltd (HSA 600:41/01-255/16/03_38) Local Contact: AB SCIEX Pte Ltd Contact no./Email: 63043722 | HSA 6004101-255-16-03_38 FSN [PDF, 136 KB] |
28 Jun 2016 | Ceramic Hip Prostheses, Smith & Nephew Orthopaedics AG (HSA 600:41/01-073/16/15_25) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-16-15_25 FSN [PDF, 83 KB] |
28 Jun 2016 | Nitram DAC MKIII Universal Steriliser, Sirona Dental Systems GmbH (HSA 600:41/01-067/16/01_54) Local Contact: Fondaco Pte Ltd Contact no./Email: 63922806
| HSA 6004101-067-16-01_54 FSN [PDF, 397 KB] |
28 Jun 2016 | PHIL (PRECIPITATING HYDROPHOBIC INJECTABLE LIQUID) NON-ADHESIVE LIQUID EMBOLIC SYSTEM, MicroVention Europe, S.A.R.L (HSA 600:41/01-057/16/02_19) Local Contact: Somnotec (S) Pte Ltd Contact no./Email: 68440002 | HSA 6004101-057-16-02_19 FSN [PDF, 149 KB] |
28 Jun 2016 | Femoral Nail A/R Ø 11x280 and T2 SCN Ø9x300, Stryker Trauma GmbH (HSA 600:41/01-014/16/07_17) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: ASEAN.PMS@stryker.com
| HSA 6004101-014-16-07_17 FSN [PDF, 68 KB] |
27 Jun 2016 | PRO-PICC and PRO-LINE Devices, Medcomp (HSA 600:41/01-278/16/02_48) Local Contact: SingMed Healthcare Systems Contact no./Email: 65474916
| HSA 6004101-278-16-02_48 FSN [PDF, 1283 KB] |
27 Jun 2016 | Alaris System Infusion PC Unit, CareFusion 303 Inc (HSA 600:41/01-087/16/02_46) Local Contact: Scanmed Technology (S) Pte Ltd Contact no./Email: 68723660 | HSA 6004101-087-16-02_46 FSN [PDF, 5662 KB] |
27 Jun 2016 | Philips DuraDiagnost X-Ray System, Phillips Healthcare (Suzhou) Co Ltd (HSA 600:41/01-026/16/24_56) Local Contact: Phllips Electronics (S) Pte Ltd Contact no./Email: 62068526 | HSA 6004101-026-16-24_56 FSN [PDF, 140 KB] |
27 Jun 2016 | Alaris System Infusion PC Unit, CareFusion 303 Inc (HSA 600:41/01-003/16/05_46) Local Contact: Becton Dickinson Holdings Pte Ltd Contact no./Email: 64322048 | HSA 6004101-003-16-05_46 FSN [PDF, 5661 KB] |
24 Jun 2016 | neoBLUE® LED Phototherapy System, Natus Medical Inc (HSA 600:41/01-113/16/01_54) Local Contact: Equip Medical Pte Ltd Contact no./Email: 65623008 | HSA 6004101-113-16-01_54 FSN [PDF, 220 KB] |
24 Jun 2016 | XARIO 200 and XARIO 100, Toshiba Medical Systems Corporation (HSA 600:41/01-064/16/03_63) Local Contact: Toshiba Medical Systems Asia Pte Ltd Contact no./Email: 62729766 | HSA 6004101-064-16-03_63 FSN [PDF, 226 KB] |
24 Jun 2016 | Cortex Screw Ø 2.7 mm, self-tapping, length 18mm, Pure Titanium, Synthes GmbH (HSA 600:41/01-002/16/25_52) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 67504213 | HSA 6004101-002-16-25_52 FSN [PDF, 192 KB] |
23 Jun 2016 | BD PhoenixSpec Calibrator Kit, Becton, Dickinson and Company (HSA 600:41/01-003/16/04_23) Local Contact: Becton Dickinson Holdings Pte Ltd Contact no./Email: 64322048 | HSA 6004101-003-16-04_23 FSN [PDF, 1618 KB] |
22 Jun 2016 | Diapanel, DiaMed GmbH (HSA 600:41/01-027/16/07_20) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 64904262 | HSA 6004101-027-16-07_20 FSN [PDF, 1818 KB] |
22 Jun 2016 | V-PRO® 1, V-PRO® 1 Plus, and V-PRO® maX Low Temperature Sterilization Systems, Steris Corporation (HSA 600:41/01-162/16/01_41) Local Contact: ITS Science & Medical Pte Ltd Contact no./Email: info@its-sciencemedical.com | HSA 6004101-162-16-01_41 FSN [PDF, 209 KB] |
21 Jun 2016 | SOMATOM Definition Flash, SOMATOM Definition Edge and SOMATOM Definition AS, Siemens Healthcare GmbH (HSA 600:41/01-022/16/28_36) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com | HSA 6004101-022-16-28_36 FSN [PDF, 156 KB] |
21 Jun 2016 | AutoPlex® System, Stryker Instruments (HSA 600:41/01-014/16/04_35) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: ASEAN.PMS@stryker.com | HSA 6004101-014-16-04_35 FSN [PDF, 192 KB] |
21 Jun 2016 | Stryker Round Fluted Burs, Stryker Instruments (HSA 600:41/01-014/16/05_49) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: ASEAN.PMS@stryker.com | HSA 6004101-014-16-05_49 FSN [PDF, 109 KB] |
21 Jun 2016 | Big Bore Oncology, Big Bore Radiology, Philips Medical Systems Inc (HSA 600:41/01-026/16/23_40) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 18007445477 | HSA 6004101-026-16-23_40 FSN [PDF, 71 KB] |
21 Jun 2016 | Monolisa HCV Ag-Ab ULTRA V2, DiaMed GmbH (HSA 600:41/01-027/16/06_60) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 64904262 | HSA 6004101-027_16_06_60 FSN [PDF, 168 KB] |
21 Jun 2016 | Access Free T3 Reagent Kit, Beckman Coulter (HSA 600:41/01-052/16/09_59) Local Contact: Beckman Coulter Singapore PteLtd Contact no./Email: 63407126 | HSA 6004101-052-16-09_59 FSN [PDF, 37 KB] |
21 Jun 2016 | AllSet+ Gold SSP, One Lambda Inc (HSA 600:41/01-220/16/01_61) Local Contact: Life Technologies Holding Contact no./Email: 63629643 | HSA 6004101-220-16-01_61 FSN [PDF, 64 KB] |
21 Jun 2016 | Mandible Distractor, Monoaxial and Proximal Foot Plate, Synthes GmbH (HSA 600:41/01-002/16/24_44) Local Contact: Johnson & Johnson Pte Ltd Contact no./Email: 68276135 | HSA 6004101-002-16-24_44 FSN [PDF, 79 KB] |
20 Jun 2016 | Activa® PC, Activa® SC, Activa® RC and Activa® PC+S Devices, Medtronic Inc (HSA 600:41/01-009/16/08_33) Local Contact: Medtronic International Limited Contact no./Email: 64365000 | HSA 6004101-009-16-08_33 FSN [PDF, 152 KB] |
20 Jun 2016 | Deep Brain Stimulation Therapy, Medtronic Inc (HSA 600:41/01-009/16/09_37) Local Contact: Medtronic International Limited Contact no./Email: 64365000 | HSA 6004101-009-16-09_37 FSN [PDF, 108 KB] |
17 Jun 2016 | Stryker Neurovascular Target Detachable Coils, Stryker Neurovascular (HSA 600:41/01-014/16/03_45) Local Contact: Stryker Singapore Pte Ltd Contact no./Email: iris.lim@stryker.com | HSA 6004101-014-16-03_45 FSN [PDF, 255 KB] |
15 Jun 2016 | Fluorocell PLT, Sysmex Corporation (HSA 600:41/01-032/16/05_57) Local Contact: Sysmex Asia Pacific Pte Ltd Contact no./Email: 6221 3629 / RA@sysmex-ap.com | HSA 6004101-032-16-05_57 FSN [PDF, 1792 KB] |
15 Jun 2016 | Point 4, Kerr Corporation (HSA 600:41/01-168/16/02_19) Local Contact: KaVo Dental Supply Contact no./Email: 62961790 | HSA 6004101-168-16-02_19 FSN [PDF, 154 KB] |
14 Jun 2016 | MyCareLink Patient Monitor, Medtronic Inc. (HSA 600:41/01-009/16/07_25) Local Contact: Medtronic International Ltd. Contact no./Email: Sherry.ann.panes@medtronic.com | HSA 6004101-009-16-07_25 FSN [PDF, 201 KB] |
13 Jun 2016 | Babytherm 8004/8010 open care units, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/16/03_17) Local Contact: Draeger Medical SEA Pte Ltd Contact no./Email: ryan.yeo@draeger.com | HSA 6004101-063-16-03_17 FSN [PDF, 8073 KB] |
13 Jun 2016 | DISCOVERY MR750W 3.0T MRI SYSTEM, GE Medical Systems LLC (HSA 600:41/01-010/16/10_18) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 62777668 | HSA 6004101-010-16-10_18 FSN [PDF, 66 KB] |
10 Jun 2016 | COBAS B 123 SENSOR CARTRIDGE BG/ISE/GLU/LAC, Roche Diagnostics GmbH (HSA 600:41/01-016/16/11_38) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com | HSA 6004101-016-16-11_38 FSN [PDF, 740 KB] |
09 Jun 2016 | Dornier Medilas H Holmium Laser System,Dornier Medilas H30 (Medilas H Solvo) holmium: YAG pulsed laser system, Dornier MedTech GmbH (HSA 600:41/01-161/16/01_08) Local Contact: Dornier MedTech Asia Pte Ltd Contact no./Email: 65726068 | HSA 6004101-161-16-01_08 FSN [PDF, 3850 KB] |
09 Jun 2016 | Dornier Medilas HRM (Medilas H UroPulse) holmium:YAG pulsed laser system, Dornier MedTech GmbH (HSA 600:41/01-161/16/02_08) Local Contact: Dornier MedTech Asia Pte Ltd Contact no./Email: 65726068 | HSA 6004101-161-16-02_08 FSN [PDF, 204 KB] |
08 Jun 2016 | Multiplate® Analyzer, Roche Diagnostics GmbH (HSA 600:41/01-016/16/10_24) Local Contact: Roche Diagnostics Asia Pacific Pte Ltd Contact no./Email: sg.regulatory@roche.com | HSA 6004101-016-16-10_24 FSN [PDF, 83 KB] |
08 Jun 2016 | Dimension® clinical chemistry system,Dimension® Creatinine (CRE2) Flex® reagent cartridge, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/27_34) Local Contact: Siemens Healthcare Pte Ltd Contact no./Email: ui-handling.sg@siemens.com | HSA 6004101-022-16-27_34 FSN [PDF, 97 KB] |
08 Jun 2016 | Zimmer Natural Nail® Cephalomedullary Nails (ZNN CMN Nails), Zimmer GmbH (HSA 600:41/01-008/16/07_09) Local Contact: Zimmer Pte Ltd Contact no./Email: 68547081 | HSA 6004101-008-16-07_09 FSN [PDF, 292 KB] |
07 Jun 2016 | Quantia Digitoxin Reagent, BioKit S.A. (HSA 600:41/01-005/16/07_23) Local Contact: Abbott Laboratories Singapore Pte Ltd Contact no./Email: 68859103 | HSA 6004101-005-16-07_23 FSN [PDF, 876 KB] |
06 Jun 2016 | Alere TESTPACK + Plus STREP A with OBC, Alere Medical Co., Ltd. (HSA 600:41/01-111/16/02_22) Local Contact: Unison Collaborative Pte Ltd Contact no./Email: info@unicoll.com.sg | HSA 6004101-111-16-02_22 FSN [PDF, 49 KB] |
03 Jun 2016 | Resolute Integrity Zotarolimus-Eluting Coronary Stent System, Medtronic Inc. (HSA 600:41/01-009/16/06_46) Local Contact: Medtronic International Limited Contact no./Email: boon.yee.ng@medtronic.com | HSA 6004101-009-16-06_46 FSN [PDF, 53 KB] |
03 Jun 2016 | PINNACLE® DESTINATION® Guiding Sheath, Terumo Medical Corporation (HSA 600:41/01-028/16/04_56) Local Contact: Terumo Singapore Pte Ltd Contact no./Email: 62913603 | HSA 6004101-028-16-04_56 FSN [PDF, 455 KB] |
02 Jun 2016 | Philips Sonalleve MR-HIFU system, Philips Oy (HSA 600:41/01-026/16/21_54) Local Contact: Philips Electronics (S) Pte Ltd Contact no./Email: 1800 744 5477 | HSA 6004101-026-16-21_54 FSN [PDF, 33 KB] |
02 Jun 2016 | ALT OSR6X07, Glucose-Stat OSR6X40, Beckman Coulter Inc. (HSA 600:41/01-052/16/08_60) Local Contact: Beckman Coulter Singapore Pte Ltd Contact no./Email: 63407126 | HSA 6004101-052-16-08_60 FSN [PDF, 111 KB] |
01 Jun 2016 | LEGION HINGE KNEE FEMORAL ASSEMBLY, Smith & Nephew Inc (HSA 600:41/01-073/16/14_52) Local Contact: Smith & Nephew Pte Ltd Contact no./Email: Singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-16-14_52 FSN [PDF, 110 KB] |
01 Jun 2016 | Alaris™ System PC unit model 8015 withsoftware versions 9.17 and 9.19, CareFusion 303 Inc (HSA 600:41/01-003/16/03_63) Local Contact: Becton Dickinson Holdings Pte. Ltd. Contact no./Email: 64322048 | HSA 6004101-003-16-03_63 FSN [PDF, 1342 KB] |
16 Dec 2015 | 3.0T 6ch Flex Coil (M0050SS), GE Medical Systems LLC (HSA 600:41/01-010/15/22_36) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 62777668 | HSA 6004101-010-15-22_36 FSN [PDF, 55 KB] |