|
DATE OF NOTIFICATION
|
TITLE
|
FSN
|
|
31 Oct 2016
|
Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/16/51_45)
Local Contact: Siemens Healthcare Pte ltd
Contact no./Email: ui-handling.sg@siemens.com
|
HSA 6004101-022-16-51_45 FSN1548 KB
|
|
31 Oct 2016
|
LMA MAD Nasal Intranasal Mucosal Atomization Device, Wolf Tory Medical, Inc (HSA 600:41/01-139/16/05_25)
Local Contact: Teleflex Medical Asia Pte Ltd
Contact no./Email: 64390000
|
HSA 6004101-139-16-05_25 FSN428 KB
|
|
31 Oct 2016
|
Axiom Artis Systems and Artis Zee Systems, Siemens Healthcare GmbH (HSA 600:41/01-022/16/50_19)
Local Contact: Siemens Healthcare Pte ltd
Contact no./Email: ui-handling.sg@siemens.com
|
HSA 6004101-022-16-50_19 FSN 11419 KB
HSA 6004101-022-16-50_19 FSN 21729 KB
|
|
27 Oct 2016
|
SOMA TOM Definition AS and SOMATOM Definition Flash, Siemens Healthcare GmbH (HSA 600:41/01-022/16/49_46)
Local Contact: Siemens Healthcare Pte ltd
Contact no./Email: ui-handling.sg@siemens.com
|
HSA 6004101-022-16-49_46 FSN3283 KB
|
|
27 Oct 2016
|
AssayTip/AssayCup, Roche Diagnostic GmbH (HSA 600:41/01-016/16/18_38)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
|
HSA 6004101-016-16-18_38 FSN191 KB
|
|
27 Oct 2016
|
Philips Brilliance and Ingenuity CT System, Philips Medical Systems Inc (HSA 600:41/01-026/16/37_48)
Local Contact: Philips Electronics (S) Pte ltd
Contact no./Email: 1800 744 5477
|
HSA 6004101-026-16-37_48 FSN207 KB
|
|
27 Oct 2016
|
X-Force™ Nephrostomy Balloon Dilation Catheter Kit With Inflation Device, C.R. Bard, Inc (HSA 600:41/01-050/16/09_56)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: Complaints.Singapore@crbard.com
|
HSA 6004101-050-16-09_56 FSN403 KB
|
|
27 Oct 2016
|
Philips Brilliance and Ingenuity CT System, Philips Medical Systems Inc (HSA 600:41/01-026/16/38_17)
Local Contact: Philips Electronics (S) Pte ltd
Contact no./Email: 1800 744 5477
|
HSA 6004101-026-16-38_17 FSN241 KB
|
|
26 Oct 2016
|
One Lambda LABType SSO and HD Typing Tests, One Lambda, Inc (HSA 600:41/01-033/16/07_34)
Local Contact: Biomed Diagnostics Pte Ltd
Contact no./Email: regulatory@biomed.com.sg
|
HSA 6004101-033-16-07_34 FSN147 KB
|
|
26 Oct 2016
|
Nellix EndoVascular Aneurysm Sealing System, Endologix, Inc (HSA 600:41/01-057/16/05_54)
Local Contact: Somnotec (S) Pte Ltd
Contact no./Email: info@somnotec.net
|
HSA 6004101-057-16-05_54 FSN901 KB
|
|
25 Oct 2016
|
SynReam Reaming Rod, Synthes GmbH (HSA 600:41/01-002/16/35_63)
Local Contact: Johnson & Johnson Pte ltd
Contact no./Email: 67504213
|
HSA 6004101-002-16-35_63 FSN2097 KB
|
|
25 Oct 2016
|
Knee Navigation System, Brainlab AG (HSA 600:41/01-047/15/09_51)
Local Contact: Brainlab Limited (Singapore Branch)
Contact no./Email: 67341701
|
HSA 6004101-047-15-09_51 FSN311 KB
|
|
21 Oct 2016
|
Fujifilm Synapse 4.0, FUJIFILM CORPORATION (HSA 600:41/01-173/16/03_41)
Local Contact: Fujifilm Asia Pacific Pte Ltd
Contact no./Email: 63809933
|
HSA 6004101-173-16-03_41 FSN151 KB
|
|
21 Oct 2016
|
Bard® Fluoro-4 Silicone Figure Four Coil, InLay, InLay VersaFit, InLay Optima Ureteral Stent, C.R. Bard, Inc (HSA 600:41/01-050/16/08_44)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: Complaints.Singapore@crbard.com
|
HSA 6004101-050-16-08_44 FSN281 KB
|
|
20 Oct 2016
|
Nihon Kohden Cardiolife AED Automated External Defibrillator, Nihon Kohden Corporation (HSA 600:41/01-074/16/01_35)
Local Contact: Nihon Kohden Singapore Pte Ltd
Contact no./Email: 63762210
|
HSA 6004101-074-16-01_35 FSN1649 KB
|
|
20 Oct 2016
|
ADVIA Centaur CA 19-9, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/48_31)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
|
HSA 6004101-022-16-48_31 FSN615 KB
|
|
19 Oct 2016
|
EZ-Tip, Research Instruments Ltd (HSA 600:41/01-210/16/02_33)
Local Contact: LabIVF Asia Pte Ltd
Contact no./Email: sales@labivf.com
|
HSA 6004101-210-16-02_33 FSN111 KB
|
|
19 Oct 2016
|
Philips Achieva 3.0T and Ingenia 3.0T MR, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/16/36_25)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
|
HSA 6004101-026-16-36_25 FSN244 KB
|
|
19 Oct 2016
|
Monaco RTP System, IMPAC Medical Systems, Inc (HSA 600:41/01-101/16/08_45)
Local Contact: Elekta Pte Ltd
Contact no./Email: elekta_global_pms@elekta.com
|
HSA 6004101-101-16-08_45 FSN62 KB
|
|
18 Oct 2016
|
Vygon Lectroguard IV Extension Tube, Vygon SA (HSA 600:41/01-051/16/01_19)
Local Contact: Star Medical Co Pte Ltd
Contact no./Email: sales@starmedical.com
|
HSA 6004101-051-16-01_19 FSN354 KB
|
|
17 Oct 2016
|
Fujifilm Ultrasonic Video Endoscope, Fujifilm Corporation (HSA 600:41/01-173/16/02_36)
Local Contact: Fujifilm Asia Pacific Pte Ltd
Contact no./Email: 63809933
|
HSA 6004101-173-16-02_36 FSN50 KB
|
|
17 Oct 2016
|
M.I Tech Choostent Covered Esophageal Stent, M.I. Tech Co Ltd (HSA 600:41/01-305/16/01_49)
Local Contact: Vitramed Singapore Pte Ltd
Contact no./Email: michael.lim@vitramed.com
|
HSA 6004101-305-16-01_49 FSN4652 KB
|
|
14 Oct 2016
|
VITROS Chemistry Products Calibrator Kit 25, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/16/02_22)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 64861151
|
HSA 6004101-303-16-02_22 FSN338 KB
|
|
14 Oct 2016
|
Bard SafeStep Huber Neede Set, Bard Access Systems, Inc. (HSA 600:41/01-050/16/07_08)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: 65805988
|
HSA 6004101-050-16-07_08 FSN200 KB
|
|
14 Oct 2016
|
ADVIA® Chemistry Direct BilirubinAssay, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/47_23)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
|
HSA 6004101-022-16-47_23 FSN275 KB
|
|
13 Oct 2016
|
GE BRIVO OEC 715/785/865, GE Hangwei Medical Systems Co., Ltd (HSA 600:41/01-010/16/16_62)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 62777668
|
HSA 6004101-010-16-16_62 FSN291 KB
|
|
13 Oct 2016
|
Ortho-Clinical VITROS Immunodiagnostic Products Intact PTH Reagent Pack, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/16/01_65)
Local Contact: Ortho-Clinical Diagnostics Singapore Pte Ltd
Contact no./Email: 64861151
|
HSA 6004101-303-16-01_65_FSN156 KB
|
|
13 Oct 2016
|
Standard Offset Cup Impactor With Pom-C Handle, Greatbatch Medical (HSA 600:41/01-014/16/14_56)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com
|
HSA 6004101-014-16-14_56 FSN389 KB
|
|
12 Oct 2016
|
Dialog+ Dialyzer machine, B. Braun Avitum AG (HSA 600:41/01-012/16/10_48)
Local Contact: B. Braun Singapore Pte Ltd
Contact no./Email: 62130933
|
HSA 6004101-012-16-10_48 FSN4150 KB
|
|
11 Oct 2016
|
ARCHITECT Lactic Acid, Abbott Laboratories (HSA 600:41/01-005/16/10_61)
Local Contact: Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 68859103
|
HSA 6004101-005-16-10_61 FSN25 KB
|
|
11 Oct 2016
|
Fortify™, Fortify Assura™, Quadra Assura™,Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™, St Jude Medical (HSA 600:41/01-025/16/02_46)
Local Contact: St Jude Medical (Singapore) Pte Ltd
Contact no./Email: 66432800
|
HSA 6004101-025-16-02_46 FSN58 KB
|
|
10 Oct 2016
|
SenTec Digital Monitoring System (SMD), SenTec AG (HSA 600:41/01-199/16/02_54)
Local Contact: Junnimed Services Pte Ltd
Contact no./Email: 65467737
|
HSA 6004101-199-16-02_54 FSN300 KB
|
|
10 Oct 2016
|
Boston Scientific Guider Softip Catheter XF, Boston Scientific Corporation (HSA 600:41/01-014/16/13_52)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: 93679174
|
HSA 6004101-014-16-13_52 FSN32 KB
|
|
7 Oct 2016
|
ID-DiaCell I-II, DiaMed GmbH (HSA 600:41/01-027/16/11_60)
Local Contact:Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
|
HSA 6004101-027-16-11_60 FSN1559 KB
|
|
7 Oct 2016
|
ICU TegoTM Needle-Free Access Device Connector, ICU Medical, Inc (HSA 600:41/01-145/16/02_51)
Local Contact:Medquest Marketing Pte Ltd
Contact no./Email: 68051250
|
HSA 6004101-145-16-02_51 FSN349 KB
|
|
6 Oct 2016
|
ADVIA Centaur Vitamin D Total, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/46_57)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg@siemens.com
|
HSA 6004101-022-16-46_57 FSN106 KB
|
|
6 Oct 2016
|
IBA Proton Therapy Systems, Ion Beam Applications S.A. (HSA 600:41/01-070/16/20_40)
Local Contact: Transmedic Pte Ltd
Contact no./Email: regulatory@transmedicgroup.com
|
HSA 6004101-070-16-20_40 FSN254 KB
|
|
6 Oct 2016
|
Low Profile Abutments, Biomet 3i (HSA 600:41/01-181/16/03_44)
Local Contact: Asia Implant Support & Services
Contact no./Email: admin@implant.com.sg
|
HSA 6004101-181-16-03_44 FSN165 KB
|
|
6 Oct 2016
|
ARCTIC SUN® 5000 Temperature Management System, C.R. Bard, Inc. (HSA 600:41/01-050/16/06_50)
Local Contact: Bard Singapore Pte Ltd
Contact no./Email: Singapore@crbard.com
|
HSA 6004101-050-16-06_50 FSN606 KB
|
|
6 Oct 2016
|
Pipeline embolization device,Alligator retrieval device,Marathon microcatheter stylets,UltraFlow HPC microcatheter stylets andXcelerator hydrophilic guidewire, Micro Therapeutics Inc dba eV3 Neurovascular (HSA 600:41/01-046/16/09_41)
Local Contact: Covidien Private Limited
Contact no./Email: 64396974
|
HSA 6004101-046-16-09_41 FSN2481 KB
|
|
6 Oct 2016
|
Tina-quant HbA1c Gen.2, Roche Diagnostics GmbH (HSA 600:41/01-016/16/16_59)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
|
HSA 6004101-016-16-16_59 FSN287 KB
|
|
5 Oct 2016
|
Clearify Visualization System, Covidien llc (HSA 600:41/01-046/16/08_49)
Local Contact: Covidien Private Limited
Contact no./Email: 64396974
|
HSA 6004101-046-16-08_49 FSN1542 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 FSN149 KB
|
|
25 May 2016
|
da Vinci Xi 5 mm-8 mm Universal Cannula Seal, da Vinci Xi 12 mm & Stapler Universal Cannula Seal, Intuitive Surgical Inc (HSA 600:41/01-070/16/15_29)
Local Contact: Transmedic Pte Ltd
Contact No.: 64776101
|
HSA 6004101-070-16-15_29 FSN4824 KB
|