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FDA USA - RECENT MEDICAL DEVICE RECALLS updated 04 19 2016

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From   Web site FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death. Use the yearly lists to find information about Class I medical device recalls and some Class II and III recalls of interest to consumers. The links give details about what to do if you own or use one of these products. If you wish to find a Class II or Class III recall, you can search the  CDRH Recalls Database .   Please note that FDA now lists medical device recall notices by the date that it posts the recall rather than the recall initiation date. You can find the date that a firm initiated a recall in the text of the recall notice. Learn more about  medical device recalls here .

CHE COS'E' LA KINESIOGRAFIA

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Il fabbricante italiano di kinesiografi ed elettromiografi BIOKET Srl (Sanbenedetto del Tronto) ha messo a disposizione  una pubblicazione,  scaricabile, gratuita, che spiega cos'猫 la kinesiografia. La pubblicazione, ricca di foto, grafici, tabelle e spiegazioni, tratta i seguenti argomenti: La kinesiografia L’esame kinesiografico Kinesiorafia in odontostomatologia Kinesiografia nelle sindromi disfunzionali dell’ATM Kinesiografia in ortodonzia Kinesiografia in protesi Kinesiografia in implantologia La pubblicazione 猫 scaricabile cliccando qui>Click Here

IMPRESSION TRAY

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Luca Martinelli Basics on dental impression tray Publication nr. 52 – 29th December 2014 Foreword Take the impression of the patient’s mouth is not a trivial operation. To the doctor’s office, a wrong impression may represent a loss of time, extensions of the patient stey in the chair, waste of expensive materials, misunderstanding with the dental laboratory, new dates which are a damage to the patient and to the dentist, with a tarnished image itself of the dental office. Over the years from dental impressions detected using wax, in the Seventeenth Century, we moved to the plaster and then to the gutta percha. Around 1925 we can find hydrocolloids, later alginates, curing silicons and polyether. From 1976 on we find addition silicon and many others will come. Trays have remained essentially the same from their first invention up to now. Perhaps that’s the reason why they have always been considered the “Cinderella” of manual dental devices yet they are of funda...

ON THE ROAD TO EU MEMBERSHIP - CANDIDATE COUNTRIES - TURKEY

Membership status Candidate country Background In 1987, Turkey applied to join what was then the European Economic Community, and in 1997 it was declared eligible to join the EU. Turkey's involvement with European integration dates back to 1959 and includes the Ankara Association Agreement (1963) for the progressive establishment of a Customs Union (ultimately set up in 1995). Accession negotiations  started in 2005, but until Turkey agrees to apply the Additional Protocol  of the Ankara Association Agreement to Cyprus, eight negotiation chapters will not be opened and no chapter will be provisionally closed. Turkey is seeing an unprecedented and continuously increasing influx of people seeking refuge from Syria which has exceeded 2.2 million to date. Overall, Turkey is the country in the world hosting the highest number of refugees, and has already spent more than 7 billion EUR of its own resources on addressing this crisis. The Commission has engaged with Turkey...

ON THE ROAD TO EU MEMBERSHIP - CANDIDATE COUNTRIES - YUGOSLAV REPUBLIC OF MACEDONIA

Membership status Candidate country Background The former Yugoslav Republic of Macedonia – along with other Western Balkans countries – was identified as a potential candidate for EU membership during the  Thessaloniki European Council  summit in 2003. The former Yugoslav Republic of Macedonia applied for EU membership in March 2004. The Commission issued a favourable opinion in November 2005, and the Council decided in December 2005 to grant the country candidate status. In October 2009, the Commission recommended that accession negotiations be opened.

ON THE ROAD TO EU MEMBERSHIP - CANDIDATE COUNTRIES - SERBIA

Membership status Candidate country Background Serbia – along with 5 other Western Balkans countries – was identified as a potential candidate for EU membership during the Thessaloniki European Council summit in 2003. In 2008, a  European partnership for Serbia  was adopted, setting out priorities for the country's membership application, and in 2009 Serbia formally applied. In March 2012 Serbia was granted EU candidate status. In September 2013 a  Stabilisation and Association Agreement  between the EU and Serbia entered into force. In line with the decision of the European Council in June 2013 to open accession negotiations with Serbia, the Council adopted in December 2013  the negotiating framework  and agreed to hold the 1st Intergovernmental Conference with Serbia in January 2014. On 21 January 2014,  the 1st Intergovernmental Conference  took place, signaling the formal start of Serbia's accession negotiations. More information ...

ON THE ROAD TO EU MEMBERSHIP - CANDIDATE COUNTRIES - MONTENEGRO

Membership status Candidate country Background In 2006 Montenegro's parliament declared independence from the State Union of Serbia and Montenegro. In 2008, the new country applied for EU membership. In 2010, the Commission issued a  favourable opinion on Montenegro's application , identifying 7 key priorities that would need to be addressed for negotiations to begin, and the Council granted it candidate status. In December 2011, the Council launched the accession process with a view to opening negotiations in June 2012. The accession negotiations with Montenegro started on 29 June 2012. More information on the country's relations with the EU

ON THE ROAD TO EU MEMBERSHIP - CANDIDATE COUNTRIES - ALBANIA

Albania Membership status Candidate country Background Albania – along with other Western Balkans countries – was identified as a potential candidate for EU membership during the  Thessaloniki European Council   summit in June 2003. In 2009, Albania submitted its formal application for EU membership. In its Opinion on Albania's application (in 2010), the Commission assessed that before accession negotiations could be formally opened, Albania still had to achieve a necessary degree of compliance with the membership criteria and in particular to meet the 12 key priorities identified in the Opinion. In October 2012, Commission recommended that Albania be granted EU candidate status, subject to completion of key measures in the areas of judicial and public administration reform and revision of the parliamentary rules of procedures. In June 2014, Albania was awarded candidate status by the EU. More information on the country's relations with the EU

III° CONVEGNO NAZIONALE WPAI - CONDIZIONAMENTO DELLO STIMOLO ADATTATIVO SUI SISTEMI PSICHICO, BIOCHIMICO E STRUTTURALE

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Venerd矛 30 settembre e sabato 1 ottobre 2016, presso il  Park Hotel Resort Paradiso del Garda a Peschiera del Garda, si terr脿 il III° Convegno WPAI Il Congresso quest 始anno si pone l 始obiettivo di confrontare e collegare le scuole ed i professionisti che si occupano di riabilitazione posturale in relazione ai condizionamenti adattativi psichici, biochimici e strutturali che inducono a variazioni dell 始assetto posturale. Per qualsiasi informazione o prenotazione: Segreteria Organizzativa WPAI: Sig. Sergio Zanfrini Tel. 348 2637890 Presidenza WPAI: Dott. Tullio Toti Tel. 045 4649244 Email: wpaitalia@gmail.com Brochure e scheda di adesione>Click Here

EU - MEDICAL DEVICES GUIDANCE

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From website The European Commission provides a range of guidance documents to assist stakeholders in implementing directives related to medical devices. Guidance MEDDEVEs The MEDDEVs promote a common approach to be followed by manufacturers and Notified Bodies that are involved in conformity assessment procedures. The MEDDEVs are drafted by authorities charged with safeguarding public health in conjunction with all stakeholders; industry associations, health professionals associations, Notified Bodies and European Standardisation Organisations. This is in accordance with the relevant annexes of the directives MEDDEVs are carefully drafted through a consultation process with all interested parties and are subject to a regular updating process These documents have particular reference codes and are endorsed at the Medical Devices Expert Group (MDEG) plenary meetings The guidelines are not legally binding. However, due to the participation of the aforementi...