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    20 JUNE 2008 Ref:MDB/A/2008/005 PRODUCT CLASS USE

    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    20 Jun 2008 — The trigger flush device delivers a nominal flow rate and activation of the trigger flush device allows a transient higher flow of fluid to ...

    23 July 2008 Ref:MDB/A/2008/009 PRODUCT CLASS ...

    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    23 Jul 2008 — REASON. Potential for the BD Luer slip syringes supplied in procedure packs to spontaneously disconnect or fail to.

    Medical Device / Equipment RECALL Date Issued

    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    15 May 2008 — REASON. Due to a manufacturing defect there is a risk of damage to the intubating stylet on its removal from the endobronchial tube.

    5th May 2008 Ref:MDB/A/2008/002 PRODUCT CLASS ...

    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    5 May 2008 — They advised that this could occur when the power supply to the unit is interrupted during an air detection alarm e.g. by manually switching ...

    Medical Device / Equipment RECALL Date Issued

    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    28 Apr 2008 — The manufacturer initiated the recall of certain lots of this product following the discovery that two symbols.

    Field Corrective Action Date Issued : 3rd June 2008 Ref: ...

    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    3 Jun 2008 — These defibrillators have specific software version (see attachment) and users must define the Setup Option of.

    Field Corrective action Date Issued : 2 JULY 2008 Ref: ...

    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    2 Jul 2008 — Small number of SynchroMed II pumps may have been manufactured without propellant, according to reports (see attachment for details), eight.

    3 JULY 2008 Ref:MDB/R/2008/010

    mdb.gov.my
    https://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    https://www.mdb.gov.my › mdb › documents
    3 Jul 2008 — A limited number of electrosurgical blades and needles may have an inadequate packaging seal, potentially compromising the sterility of the ...

    Medical Device / Equipment RECALL Date Issued

    mdb.gov.my
    https://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    https://www.mdb.gov.my › mdb › documents
    15 May 2008 — REASON. Contaminated Heparin Used in Carmeda Coatings. Applied to Selected Cardiopulmonary Bypass. Products.

    Medical Device / Equipment RECALL Date Issued

    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    25 Apr 2008 — Medical Devices Bureau, Ministry of Health Malaysia. Level 5, Block E6, Complex E,. Federal Government Administration Centre,.

    Risk Review Analysis Summary

    mdb.gov.my
    http://www.mdb.gov.my › smiths_medical05
    mdb.gov.my
    http://www.mdb.gov.my › smiths_medical05
    4 Jul 2011 — Summary. As of July 2011, Smiths Medical has received a total of 2 confirmed reports of incorrect information with.

    Unit list-HM355S

    mdb.gov.my
    http://www.mdb.gov.my › mdb › thermofisher04
    mdb.gov.my
    http://www.mdb.gov.my › mdb › thermofisher04
    16 Aug 2010 — Country code. Customer No. Customer name. Delivery date. Sum. 49738. 905200 China. CN. 205395 CHINA MEHECO CORPORATION, BEIJ. 13.01.2011.

    NIKKISO Europe GmbH - Desbrocksriede 1 30855 ...

    mdb.gov.my
    http://www.mdb.gov.my › documents › fca2
    mdb.gov.my
    http://www.mdb.gov.my › documents › fca2
    31 Aug 2011 — We are writing to inform you that Nikkiso Europe is initiating a Field Safety Corrective Action of the Haemofiltration device AQUARIUS.

    Product Advisory Notice

    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    11 Aug 2010 — TomoTherapy has discovered an anomaly with the 4.0.2 Plan Report during internal testing. When using. TomoDirect 3DCRT, the outline of the ...

    Product Advisory Notice

    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    11 Aug 2010 — TomoTherapy has received a few reports that the Film Analyzer Transverse Laser Point Tool can return an erroneous lateral offset indicating ...

    5 February 2009 Ref:MDB/A/2009/001 PRODUCT CLASS ...

    mdb.gov.my
    http://www.mdb.gov.my › alert_200901_01
    mdb.gov.my
    http://www.mdb.gov.my › alert_200901_01
    5 Feb 2009 — RECOMMENDATION. Users of the abovementioned device (if available) should contact the distributors/supplier of this device.

    PRODUCT CORRECTION Specific STERRAD® 50 ...

    mdb.gov.my
    https://www.mdb.gov.my › mdb › alert › alert_200901_03
    mdb.gov.my
    https://www.mdb.gov.my › mdb › alert › alert_200901_03
    2 Feb 2009 — Advanced Sterilization Products (ASP) is notifying you of a remote circumstance that could cause a capacitor in the vacuum pump component ...

    Symbiq AIL Recall Notification FINAL _3_

    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    11 Jun 2010 — This is a critical update to our April 2010 “Clinical Bulletin”. Hospira continues to receive reports of its Symbiq ™ Infusion System ...

    arrow.

    mdb.gov.my
    https://www.mdb.gov.my › ArrowCatheter01-01
    mdb.gov.my
    https://www.mdb.gov.my › ArrowCatheter01-01
    28 Dec 2010 — When the IAB becomes stuck in sheath, the user is unable to move the IAB catheter forward or backward, potentially causing a delay in ...

    Baxter

    mdb.gov.my
    https://www.mdb.gov.my › 200904_baxter
    mdb.gov.my
    https://www.mdb.gov.my › 200904_baxter
    18 Mar 2009 — as a Class I recall. Although this is the most serious of classifications, this does not require the return of infusion pumps, ...

    Baxter

    mdb.gov.my
    http://www.mdb.gov.my › documents › fca3
    mdb.gov.my
    http://www.mdb.gov.my › documents › fca3
    19 Sept 2011 — As a distributor of Nikkiso Aquarius system, Baxter would like to inform you that Nikkiso Europe has initiated a Field Safety Corrective ...

    URGENT FIELD SAFETY NOTICE

    mdb.gov.my
    http://www.mdb.gov.my › May09_JnJLetter_CypherSelect
    mdb.gov.my
    http://www.mdb.gov.my › May09_JnJLetter_CypherSelect
    11 May 2009 — Over the last few months, we have had an increase in the number of complaints relating to the occurrence of cracks in the balloon inflation ...

    Recall Acknowledgement & - Stock Status Form

    mdb.gov.my
    http://www.mdb.gov.my › ArrowCatheter02-01
    mdb.gov.my
    http://www.mdb.gov.my › ArrowCatheter02-01
    List on the form below the product code and quantity that you will be returning to Arrow International. If there are no lots affected by this recall check ...

    11 May 2009 Encik Zamanee Bin Abdul Rahman ...

    mdb.gov.my
    http://www.mdb.gov.my › documents › alert
    mdb.gov.my
    http://www.mdb.gov.my › documents › alert
    11 May 2009 — Cordis has learnt that over last few months there was an increase in the number of complaints relating to the occurrence of cracks in the ...

    Product Advisory Notice

    mdb.gov.my
    http://www.mdb.gov.my › alert › SA-TomotherapyP_B
    mdb.gov.my
    http://www.mdb.gov.my › alert › SA-TomotherapyP_B
    31 Jul 2009 — TomoTherapy Inc. wishes to alert you of an issue that was discovered on the Hi-Art System during the course of ongoing testing.

    Medical Devices Bureau, Ministry of Health Malaysia

    mdb.gov.my
    http://www.mdb.gov.my › alert › 20090824-mdb
    mdb.gov.my
    http://www.mdb.gov.my › alert › 20090824-mdb
    24 Aug 2009 — Medical Devices Bureau, Ministry of Health Malaysia. Level 5, Plot 3C4,. No. 26, Jalan Persiaran Perdana,. Precint 3, 62675 Putrajaya.

    Urgent Field Safety Notice Medical Device Correction

    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    8 Nov 2010 — Issue: TomoTherapy has discovered an anomaly during internal testing. When a TomoDirect procedure has an.

    K981349 - Accessdata.fda.gov

    mdb.gov.my
    http://www.mdb.gov.my › freesales › viewfile
    mdb.gov.my
    http://www.mdb.gov.my › freesales › viewfile
    DEPARTMENT OF HEALTH & HUMAN SERVICES. Public Health Service. Food and Drug Administration. 9200 Corporate Boulevard. Rockville MD 20850. MAY 1 8 1998.

    FEB 2 4 2004 - Accessdata.fda.gov

    mdb.gov.my
    http://www.mdb.gov.my › freesales › viewfile
    mdb.gov.my
    http://www.mdb.gov.my › freesales › viewfile
    We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially ...

    AG2721 - Accessdata.fda.gov

    mdb.gov.my
    http://www.mdb.gov.my › myform › freesales › viewfile
    mdb.gov.my
    http://www.mdb.gov.my › myform › freesales › viewfile
    We have reviewed your Section 5 10(k) premarket notification of intent to market the device referenced above and have determined the device is substantially ...

    PERUSAHAAN PELINDUNG GETAH (M) SDN BHD Amended

    mdb.gov.my
    http://www.mdb.gov.my › freesales › viewfile
    mdb.gov.my
    http://www.mdb.gov.my › freesales › viewfile
    2 Oct 2003 — It is made from natural rubber latex using USP cornstarch as donning powder. The manufacturing process includes pre and post leaching stages ...

    TECHNISCHES DATENBLATT

    mdb.gov.my
    http://www.mdb.gov.my › freesales › viewfile
    mdb.gov.my
    http://www.mdb.gov.my › freesales › viewfile
    ulma International GmbH. Fon: +49 (0)731 92 60 43 .0 www.ulma.de. Pfaffenweg 35. Fax: +49 (0)731 92 60 43 .10 info@ulma.de. 89231 Neu-Ulm.

    Page 1 of 2 TRAININGS SANCTIONED BY THE ...

    mdb.gov.my
    http://mdb.gov.my › mdb › index2
    mdb.gov.my
    http://mdb.gov.my › mdb › index2
    21 May 2018 — Date (Day) : JULY 23, 2018 (MONDAY). Time. : 08.30 AM - 05.00 PM. Venue. : BILIK SEMINAR 1, LEVEL G, PRIMA 9, 63000 CYBERJAYA.

    Conformity Assessment Body (CAB) Application Form

    mdb.gov.my
    https://mdb.gov.my › mdb
    mdb.gov.my
    https://mdb.gov.my › mdb
    27 Feb 2015 — Note: This form should also be used for making applications for re-application and extensions to scope. Provide only relevant information ...

    APPLICATION FORM - Medical Device Authority (MDA)

    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    Application Form. 2. Full resume of technical personnel and management. 3. Copy of GLP trainer's resume. 4. Copies of personnel competency and training ...

    Baxter

    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    10 Jun 2010 — United States. This announcement affects the U.S. market ONLY and will be carried out over a period of time. As previously disclosed, Baxter ...

    WEBSITE ANNOUNCEMENT CIRCULAR LETTER OF THE ...

    mdb.gov.my
    https://mdb.gov.my › mdb
    mdb.gov.my
    https://mdb.gov.my › mdb
    This Circular Letter was prepared by the Medical Device Authority (MDA) to facilitate the stakeholder and industry in the implementation of Medical Device ...

    list of acknowledgement on notification for demonstration

    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    8 Sept 2018 — VIMAP TECHNOLOGIES, SPAIN. Demostration. Hospital Sungai Buloh. 24 June - 23. September 2018. MDA/DM/2018/43. Medtronic Malaysia Sdn Bhd.

    Medtronic International Ltd. - Medical Device Authority (MDA)

    mdb.gov.my
    https://www.mdb.gov.my › documents › recall
    mdb.gov.my
    https://www.mdb.gov.my › documents › recall
    6 May 2010 — Medtronic is informing you of a rare device software issue in the ICD and CRT-D device models listed above. A.

    Medical Device Authority (MDA)

    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    11 Jan 2016 — 1) The purpose of this circular is to set the policy for implementation and enforcement under the Medical Device Act 2012 (Act 737) relating ...

    SEMINAR WITH MEDICAL DEVICE INDUSTRY 2018

    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    18 Apr 2018 — APRIL 2018). Date: 18 April 2018. Time: 8.30 am - 5.00 pm. Venue: Marriott Hotel, Putrajaya. Content of event on DAY 1:.

    Product Advisory Notice

    mdb.gov.my
    http://www.mdb.gov.my › documents › recall
    mdb.gov.my
    http://www.mdb.gov.my › documents › recall
    23 Apr 2010 — Issue: TomoTherapy has been informed by Standard Imaging, supplier of the TomoElectrometer, that units with firmware version 2.9 and 3.0 may ...

    WEBSITE ANNOUNCEMENT CIRCULAR LETTER OF THE ...

    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    This Circular Letter was prepared by the Medical Device Authority (MDA) to facilitate the stakeholder and industry in the implementation of Medical Device ...

    SEMINAR WITH MEDICAL DEVICE INDUSTRY 2018

    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    Below are the details of the seminar: DAY 1 (18TH APRIL 2018). Date: 18 April 2018. Time: 8.30 am - 5.00 pm. Venue: Putra World Trade Centre (PWTC), ...

    LIFEPAK® 15 Monitor/Defibrillator

    mdb.gov.my
    http://www.mdb.gov.my › documents › recall
    mdb.gov.my
    http://www.mdb.gov.my › documents › recall
    2 Mar 2010 — What is the issue? Physio-Control, Inc. a division of Medtronic, Inc. is conducting a voluntary correction for a.

    MR. AZHAR MR. SAIFUL FACILITIES CONNECTIVITY ...

    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    Rental begins from August 2017. • Minimum rental duration is 3 years. • For every 1,000 sqft, 1 parking space is allocated. • Car park rate is RM120 / month.

    Page 1 of 2 TRAININGS SANCTIONED BY THE ...

    mdb.gov.my
    https://www.mdb.gov.my › mdb
    mdb.gov.my
    https://www.mdb.gov.my › mdb
    Date (Day) : NOVEMBER 13 & 14, 2018 (TUESDAY & WEDNESDAY). Time. : 08.30 AM - 05.00 PM. Venue. : BILIK SEMINAR 1, LEVEL G, PRIMA 9, 63000 CYBERJAYA.

    pihak berkuasa peranti perubatan

    mdb.gov.my
    http://www.mdb.gov.my › mdb › index2
    mdb.gov.my
    http://www.mdb.gov.my › mdb › index2
    Please skip this question if your organization/company is not an “establishment” according to the definition under Section 2 of Act 737.

    Remarks Date Sponsor Received Report of SAE (dd/mm/ ...

    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    Status: Remarks. Date Sponsor Received Report of SAE (dd/mm/yyyy). Country Code. Study Center. Patient ID Code. SAE ID Code.

    URGENT FIELD SAFETY NOTICE

    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents
    1 Sept 2010 — Description of problem: Thoratec has become aware of a recent trend in complaints related to the HM II System Controller.

    BD-BDKS-045 (Versi 1)

    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    Notes: * is mandatory. Only completed form will be processed by our officers. Local Company. Individual. Malaysian. Multinational Comp. Organisation.

    hands-on training for establishment licensing and medical ...

    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    16 Jul 2013 — 9.45am Overview On Establishment Licensing Module In MeDC@St. And Hands-on Session. 10.45am Break. 11.30am Requirements On Medical Device ...

    Email: seminar.industri@mdb.gov.my

    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    *Payment should be made to “KUMPULAN WANG PIHAK. BERKUASA PERANTI PERUBATAN”. *Payment in Malaysia Ringgit (MYR only). *Please bring the BANK DRAFT on the ...

    hands-on training for establishment licensing and ...

    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    mdb.gov.my
    https://mdb.gov.my › mdb › index2
    25 Jul 2013 — 9.15am Introduction on MeDC@St. 9.45am Requirements On Establishment License Application. • Quality Management System.

    Product Advisory Notice

    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents › recall › 4...
    mdb.gov.my
    http://www.mdb.gov.my › mdb › documents › recall › 4...
    27 Apr 2010 — Issue: In the unlikely event gantry roll correction is applied to a phantom image which was translated (via DQA.

    Product Advisory Notice

    mdb.gov.my
    http://www.mdb.gov.my › documents › recall
    mdb.gov.my
    http://www.mdb.gov.my › documents › recall
    23 Apr 2010 — Issue: TomoTherapy has discovered during internal testing that the median structure dose reported by the.

    COVIDIEN/MEDTRONIC PB980 VENTILATOR

    mdb.gov.my
    http://www.mdb.gov.my › documents › index2
    mdb.gov.my
    http://www.mdb.gov.my › documents › index2
    25 Sept 2017 — We are contacting you regarding a communication we have received from the Therapeutic Goods Administration.

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    Malaysia
    Sungai Petani, Kedah
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    Husein Zolkepli
    husein.zol05@gmail.com