Date of Notification | Title | FSN |
|---|
31 Aug 2017 | BD Vacutainer® EDTA Blood Collection Tubes, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/17/16_48)
Local Contact: Becton Dickinson Holdings Pte. Ltd. (BD)
Contact no./Email: 6432 2048 | HSA 6004101-003-17-16_48 FSN_Redacted [PDF, 781 KB] |
31 Aug 2017 | META-TAN 10MM X 38CM RIGHT, Smith & Nephew Inc (HSA 600:41/01-073/17/11_64)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-17-11_64 FSN [PDF, 135 KB] |
31 Aug 2017 | META-TAN lOMM X 34CM LEFT, Smith & Nephew Inc (HSA 600:41/01-073/17/12_51)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com | HSA 600 41 01-073 17 12_51 FSN [PDF, 135 KB] |
30 Aug 2017 | 5X55MM KII OPTICAL Z-THREAD DUAL PACK, Applied Medical Resources Corporation (HSA 600:41/01-163/17/01_48)
Local Contact: Ikon Medical Pte Ltd
Contact no./Email: 6336 5813 / sales@ikonmedical.com | HSA 6004101-163-17-01_48 FSN_Redacted [PDF, 117 KB] |
29 Aug 2017 | Merlin PCS 3650 Software Upgrade Kit, St. Jude Medical, Cardiac Rhythm Management Division (HSA 600:41/01-025/17/02_54)
Local Contact: St. Jude Medical (Singapore) Pte Ltd
Contact no./Email: 6643 2800 | HSA 6004101-025-17-02_54_FSN_Redacted [PDF, 103 KB] |
29 Aug 2017 | Merlin PCS 3650 Software Upgrade Kit, St. Jude Medical, Cardiac Rhythm Management Division (HSA 600:41/01-025/17/03_54)
Local Contact: St. Jude Medical (Singapore) Pte Ltd
Contact no./Email: 6643 2800 | HSA 6004101-025-17-03_54_FSN_Redacted [PDF, 159 KB] |
25 Aug 2017 | GENTIAN BECKMAN COULTER CYSTATIN C, Gentian AS (HSA 600:41/01-052/17/10_58)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 63407126 | HSA 6004101-052-17-10_58 FSN_Redacted [PDF, 3468 KB] |
24 Aug 2017 | Versys 6” Beaded Full Coat Plus Hip Prosthesis ; Zimmer Segmental System, Distal Femoral Prosthesis, Zimmer, Inc. (HSA 600:41/01-008/17/10_51)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7250 | HSA 6004101-008-17-10_51 FSN_Redacted [PDF, 151 KB] |
24 Aug 2017 | KALARE, HDR-08A, Toshiba Medical Systems Corporation (HSA 600:41/01-064/17/03_63)
Local Contact: Toshiba Medical Systems Asia Pte Ltd
Contact no./Email: 6272 9766 | HSA 6004101-064-17-03_63 FSN [PDF, 71 KB] |
24 Aug 2017 | Vanguard Open Box Posterior Stabilized Femoral Components, Zimmer, Inc. (HSA 600:41/01-008/17/11_62)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com | HSA 6004101-008-17-11_62 FSN_Redacted [PDF, 304 KB] |
24 Aug 2017 | Persona Tibial Plate Provisionals and Tibial Sizing Plates, Zimmer, Inc. (HSA 600:41/01-008/17/12_35)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com | HSA 6004101-008-17-12_35 FSN_Redacted [PDF, 270 KB] |
23 Aug 2017 | Servo Air, Maquet Critical Care AB (HSA 600:41/01-081/17/03_37)
Local Contact: Maquet South East Asia Pte Ltd
Contact no./Email: 6296 1992 | HSA 6004101-081-17-03_37 FSN_Redacted [PDF, 104 KB] |
22 Aug 2017 | IMPAC Monaco RTP System, IMPAC, Inc (HSA 600:41/01-101/17/05_44)
Local Contact: Elekta Pte Ltd
Contact no./Email: 6221 2322 / Elekta_Global_PMS@elekta.com | HSA 6004101-101-17-05_44 FSN_Redacted [PDF, 669 KB] |
22 Aug 2017 | Impac Monaco RTP System, IMPAC, Inc (HSA 600:41/01-101/17/06_50)
Local Contact: Elekta Pte Ltd
Contact no./Email:6221 2322 / Elekta_Global_PMS@elekta.com | HSA 6004101-101-17-06_50_FSN_Redacted [PDF, 245 KB] |
22 Aug 2017 | IMPAC Monaco RTP System, IMPAC, Inc (HSA 600:41/01-101/17/04_49)
Local Contact: Elekta Pte Ltd
Contact no./Email: 6221 2322 / Elekta_Global_PMS@elekta.com | HSA 6004101-10-117-04_49 FSN_Redacted [PDF, 687 KB] |
18 Aug 2017 | Remel Wellcolex Color Shigella, Remel Europe Ltd (HSA 600:41/01-178/17/04_38)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6499 9999/ cs.mbd.sg@thermofisher.com | HSA 6004101-178-17-04_38 FSN_Redacted [PDF, 128 KB] |
18 Aug 2017 | CLINITEK® Atlas 10 Reagent Pak & CLINITEK® Atlas PRO 12 Reagent Pak, Siemens Healthcare Diagnostics, Inc. (HSA 600:41/01-022/17/24_34)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com | HSA 6004101-022-17-24_34 FSN [PDF, 14 KB] |
17 Aug 2017 | Artis one systems with DP Transceiver below revision 03, Siemens Shenzhen Magnetic Resonance Ltd (HSA 600:41/01-022/17/25_35)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com | HSA 6004101-022-17-25_35 FSN_Redacted [PDF, 2679 KB] |
16 Aug 2017 | Abbott Realtime HIV-1 Qualitative, Abbott Molecular Inc (HSA 600:41/01-005/17/13_38)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: 6914 8252 / FSN_Inquiry@Abbott.com | HSA 6004101-005-17-13_38 FSN_Redacted [PDF, 145 KB] |
16 Aug 2017 | Mako RIO Partial Knee Arthroplasty (PKA) and Total Hip Arthroplasty (THA) Software Applications, MAKO Surgical Corp. (HSA 600:41/01-070/17/15_37)
Local Contact: Transmedic Pte Ltd
Contact no./Email: Email: 6477 3869 / regulatory@transmedicgroup.com | HSA 6004101-070-17-15_37 FSN_Redacted [PDF, 88 KB] |
16 Aug 2017 | Remel Streptex Rapid Latex Agglutination Test, Remel Europe Ltd (HSA 600:41/01-148/17/03_23)
Local Contact: Thermo Scientific Microbiology Pte Ltd
Contact no./Email: 6499 9992 / cs.mbd.sg@thermofisher.com | HSA 6004101-148-17-03_23 FSN_Redacted [PDF, 166 KB] |
16 Aug 2017 | UniPerc Adjustable Flange Tracheostomy Tube 15mm Connector Soft Seal Cuff, Smiths Medical Czech Republic A.S. (HSA 600:41/01-017/17/02_52)
Local Contact: IDS Medical Systems (S) Pte Ltd | HSA 6004101-017-17-02_52 FSN_Redacted [PDF, 430 KB] |
15 Aug 2017 | Allura Xper R9 and Azurion R1.1, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/17/12_40)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477 | HSA 6004101-026-17-12_40 FSN_Redacted [PDF, 367 KB] |
15 Aug 2017 | VITROS® Immunodiagnostic Products Signal Reagent, Ortho- Clinical Diagnostics (HSA 600:41/01-303/17/10_67)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 6486 1151 | HSA 6004101-303-17-10_67 FSN_Redacted [PDF, 1170 KB] |
14 Aug 2017 | Lysercell WDF (WDF-200A), Sysmex Corporation (HSA 600:41/01-032/17/03_67)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 65 221 3629 / RA@sysmex-ap.com | HSA 6004101-032-17-03_67 FSN_Redacted [PDF, 749 KB] |
11 Aug 2017 | Oncentra® Brachy, Nucletron B.V. (HSA 600:41/01-101/17/03_19)
Local Contact: Elekta Pte Ltd
Contact no./Email: 6221 2322 / Elekta_Global_PMS@elekta.com | HSA 6004101-101-17-03_19 FSN_Redacted [PDF, 216 KB] |
11 Aug 2017 | LOCKING COMPRESSION PLATE (LCP) DRILL SLEEVE, Synthes GmbH (HSA 600:41/01-002/17/09_25)
Local Contact: Johnson & Johnson Pte Ltd
Contact no./Email: 6918 7781 | HSA 6004101-002-17-09_25 FSN_Redacted [PDF, 137 KB] |
11 Aug 2017 | Nasal Cannula, Adult, Ningbo Fuchun Co., Ltd (HSA 600:41/01-314/17/01_18)
Local Contact: Age D’or Healthcare Pte Ltd
Contact no./Email: 6776 5228 | HSA 6004101-314-17-01_18 FSN [PDF, 3420 KB] |
10 Aug 2017 | Cell Saver Elite Disposable processing kits, Haemonetics Corporation (HSA 600:41/01-070/17/14_49)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com | HSA 6004101-070-17-14_49 FSN_Redacted [PDF, 157 KB] |
10 Aug 2017 | Cobas 8000 core unit, Roche Diagnostics GmbH (HSA 600:41/01-016/17/16_65)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com | HSA 6004101-016-17-16_65 FSN [PDF, 348 KB] |
08 Aug 2017 | Mako RIO Internal cPCI Card Cage, Mako Surgical Corporation (HSA 600:41/01-070/17/13_54)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com | HSA 6004101-070-17-13_54 FSN_Redacted [PDF, 92 KB] |
08 Aug 2017 | Covidien Emprint™ Ablation System, Covidien llc (HSA 600:41/01-046/17/06_64)
Local Contact: Covidien Pte Ltd
Contact no./Email: 6439 6933 | HSA 6004101-046-17-06_64 FSN_Redacted [PDF, 2201 KB] |
07 Aug 2017 | Alinity hq Analyzer, Abbott GmbH & Co. KG (HSA 600:41/01-005/17/12_65)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: 6941 8000 / FSN@enquiry@abbott.com | HSA 6004101-005-17-12_65 FSN [PDF, 112 KB] |
03 Aug 2017 | DiaSys Creatinine PAP FS, DiaSys Diagnostic Systems GmbH (HSA 600:41/01-032/17/02_34)
Local Contact: Sysmex Asia Pacific Pte Ltd
Contact no./Email: 6221 3629 / RA@sysmex-ap.com | HSA 6004101-032-17-02_34 FSN [PDF, 230 KB] |
02 Aug 2017 | VERSAJET II Hydrosurgery System Console, Smith & Nephew Inc (HSA 600:41/01-073/17/10_18)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com | HSA 6004101-073-17-10_18 FSN [PDF, 118 KB] |
01 Aug 2017 | Cosman Medical Nitinol RF (TCN) Reusable Electrodes, Cosman Medical Inc. (HSA 600:41/01-313/17/01_56)
Local Contact: Kromax South Asia Pte Ltd
Contact no./Email: 6720 0203 | HSA 60041-01-313-17-01_56 FSN [PDF, 498 KB] |
01 Aug 2017 | Cystoscopy bridges and working inserts, Olympus Winter & Ibe GmbH (HSA 600:41/01-004-17/05_62)
Local Contact: Olympus Singapore Pte Ltd
Contact no./Email: 6883 4214 / mes-ra.osp@olympus-ap.com | HSA 6004101-004-17-05_62 FSN_Redacted [PDF, 1524 KB] |
01 Aug 2017 | Sekisui Medical Mediace TPLA, Sekisui Medical Mediace RPR Gen 2, Sekisui Medical Co. Ltd (HSA 600:41/01-016/17/15_61)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com | HSA 6004101-016-17-15_61 FSN [PDF, 558 KB] |
05 Jul 2017 | Roche Diagnostics cobas e 602, cobas e 601 and E170 modules, Roche Diagnostics GmbH (HSA 600:41/01-016/17/12_58)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com | HSA 6004101-016-17-12_58v2 FSN [PDF, 3557 KB] |
12 Jan 2017 | Boston Scientific EMBLEM S-ICD Programmer, Boston Scientific Corporation (HSA 600:41/01-007/17/01_35)
Local Contact: Boston Scientific Asia Pacific Pte Ltd
Contact no./Email: 6418 8888 / Singapore_FSCA_Query@hsci.com | HSA 6004101-007-17-01_35 FSN_Redacted [PDF, 2567 KB] |
27 Dec 2016 | Ortho-Clinical VITROS Chemistry Products Na+ Slides, Ortho-Clinical Diagnostic Inc (HSA 600:41/01-303/16/08_60)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 64861151 | HSA 6004101-303-16-08_60 FSN Part 2_Redacted [PDF, 359 KB] |
23 May 2016 | 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 [PDF, 216 KB] |
28 Mar 2016 | DiaMed Diaclon Anti-N, DiaMed GmbH (HSA 600:41/01-027/16/03_22)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 5978 | HSA 6004101-027-16-03_22 FSN_Redacted [PDF, 2998 KB] |
