SUPER IMPLANT

Informazioni principali

  • Nome commerciale:
  • SUPER IMPLANT
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Dispositivo medico

Documenti

  • per il pubblico:
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  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


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Localizzazione

  • Disponibile in:
  • SUPER IMPLANT
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • IMPIANTI DENTALI

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • S
  • Data dell'autorizzazione:
  • 19-03-2010
  • Ultimo aggiornamento:
  • 09-08-2016
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.

    Richiedi il foglio illustrativo per il pubblico.

22-12-2018

Bruno Bruins investeert in veiligheid van implantaten

Bruno Bruins investeert in veiligheid van implantaten

Voor het plaatsen van een implantaat bestaat vaak een medische noodzaak, maar niet altijd. Zoals bij alle medische ingrepen moeten de voordelen en de risico’s worden afgewogen. Het is cruciaal dat artsen over de risico’s van implantaten in gesprek gaan met de patiënt, zodat ze samen kunnen beslissen over de beste behandeling. Daarvoor is de juiste informatie nodig. Patiënten moeten weten waarom de plaatsing van een implantaat nodig is, maar ook welke risico’s (de operatie met) het implantaat met zich mee...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-12-2018

TGA statement on Allergan breast implant withdrawal in Europe

TGA statement on Allergan breast implant withdrawal in Europe

Allergan has withdrawn textured breast implants in Europe

Therapeutic Goods Administration - Australia

15-12-2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Published on: Fri, 14 Dec 2018 The EFSA Scientific Network on bovine spongiform encephalopathies and other transmissible spongiform encephalopathies (BSE‐TSE) held its 13th meeting on 15‐16 October 2018 in Parma. The meeting served as an opportunity to exchange scientific information on BSE‐TSE related issues among EU Member States, countries from the European Free Trade Association (EFTA), EFSA, the European Commission and ad hocparticipants. In this occasion, ad hoc representation included the World A...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Accra Super Market Issues Allergy Alert On Undeclared Peanuts In 'Suya Barbecue Seasoning'

Accra Super Market Issues Allergy Alert On Undeclared Peanuts In 'Suya Barbecue Seasoning'

Accra Super Market of Worcester MA, is recalling 0.53 lbs packages of "Suya Barbecue Seasoning" because it may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

14-11-2018

FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices

FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices

FDA alerted health care providers and patients about the serious complications that can occur when using medications not approved for use with implanted pumps that deliver medication into the spinal fluid to treat or manage pain.

FDA - U.S. Food and Drug Administration

14-11-2018

Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump.

FDA - U.S. Food and Drug Administration

8-11-2018

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Published on: Wed, 07 Nov 2018 00:00:00 +0100 In 2017, EFSA published a ‘simplified’ food safety management system (FSMS) for certain small retail establishments (butcher, grocer, baker, fish and ice cream shop) based on the application of prerequisite programme (PRP) criteria. The aim of this opinion was to develop similar FSMSs for other small retail enterprises including retail distribution centres, supermarkets, restaurants (including pubs and other catering activities) and food donation. The latter...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

22-10-2018

October 18, 2018: Grand Jury Returns Superseding Indictment In Shamo Case; Adds Distribution Of Fentanyl Count Resulting In Death

October 18, 2018: Grand Jury Returns Superseding Indictment In Shamo Case; Adds Distribution Of Fentanyl Count Resulting In Death

October 18, 2018: Grand Jury Returns Superseding Indictment In Shamo Case; Adds Distribution Of Fentanyl Count Resulting In Death

FDA - U.S. Food and Drug Administration

10-10-2018

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.

FDA - U.S. Food and Drug Administration

14-9-2018

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s commitment to studying breast implant safety

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s commitment to studying breast implant safety

FDA Statement on agency’s commitment to studying breast implant safety Short Title: FDA Statement on agency’s commitment to studying breast implant safety

FDA - U.S. Food and Drug Administration

10-9-2018

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Health Canada's sampling and evaluation program has determined the Super Cool Slime products donot meet the Canadian toy safety requirements related to boric acid content.

Health Canada

31-8-2018

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study. The US Food and Drug Administration (FD...

FDA - U.S. Food and Drug Administration

16-8-2018

Zakah Life Recalls Kratom Because Of Possible Health Risk

Zakah Life Recalls Kratom Because Of Possible Health Risk

Zakah Life, LLC of Ankeny, Iowa, is recalling the following Kratom products (Super Green Maeng Da Premium Kratom powder, Powerful Red Vein Bali Premium Kratom powder, Super Green Maeng Da Premium Kratom capsules, and Powerful Red Vein Bali Premium Kratom capsules) with expiration dates prior to 01/01/2023 because they have the potential of being contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weak...

FDA - U.S. Food and Drug Administration

11-7-2018

OCOOW LLC recalls Odie's Solvent-Free Super Penetrating Oil and Odie's Safer Solvent

OCOOW LLC recalls Odie's Solvent-Free Super Penetrating Oil and Odie's Safer Solvent

The recalled products do not have proper consumer chemical hazard packaging and labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

31-5-2018

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

Abbott is communicating to physicians about a field corrective action related to the HeartMate 3™ Left Ventricular Assist Device (LVAD). Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting.

FDA - U.S. Food and Drug Administration

30-5-2018

FDA approves first artificial iris

FDA approves first artificial iris

FDA approves first artificial iris, a surgically implanted device to treat aniridia or other damage to the iris

FDA - U.S. Food and Drug Administration

9-5-2018

Breast implants and anaplastic large cell lymphoma

Breast implants and anaplastic large cell lymphoma

Update on number of confirmed BIA-ALCL cases in Australia

Therapeutic Goods Administration - Australia

8-5-2018

Veterinary Feed Directive (VFD)

Veterinary Feed Directive (VFD)

A VFD drug is intended for use in animal feeds, and such use of the VFD drug is permitted only under the professional supervision of a licensed veterinarian.

FDA - U.S. Food and Drug Administration

6-4-2018

5 Things to Know About Breast Implants

5 Things to Know About Breast Implants

The U.S. Food and Drug Administration regulates breast implants as medical devices. Learn about the risks of these products, and consider this advice.

FDA - U.S. Food and Drug Administration

18-3-2018

Medical Devices Safety Update Volume 6, Number 2, March 2018

Medical Devices Safety Update Volume 6, Number 2, March 2018

Preventable alarm issues; Review into cochlear implants; NHS cylinder alert; recent safety alerts

Therapeutic Goods Administration - Australia

4-1-2016

The Danish Medicines Agency has a new website

The Danish Medicines Agency has a new website

Today, the Danish Medicines Agency launched its new website – laegemiddelstyrelsen.dk/en – where you can read about and subscribe to news about licensing and supervision of medicines, side effects, reimbursement, pharmacies and medical devices.

Danish Medicines Agency

16-3-2015

New management at the DHMA

New management at the DHMA

As from 13 March 2015, Jakob Cold has been appointed Acting Director General of the Danish Health and Medicines Authority. Anne-Marie Vangsted will continue as Director with special responsibility for the DHMA's supervision.

Danish Medicines Agency

3-2-2015

New director at the DHMA

New director at the DHMA

On 1 February 2015, Anne-Marie Vangsted, Acting Head of Division, took up the position as Director with responsibility for supervision at the Danish Health and Medicines Authority. The new position as director was created as part of our action plan aimed at modernising the supervisory function, in which Anne-Marie Vangsted has played a key role since we presented the plan on 15 September 2014.

Danish Medicines Agency

5-1-2015

Fees for medical devices in 2015

Fees for medical devices in 2015

The fees for medical devices have been adjusted in accordance with Danish Government regulations, including the fees for registration of manufacturers and devices, importers and distributors, assessment of applications for the authorisation for clinical investigation of medical devices, and amendments to investigations, as well as supervision and control of notified bodies in Denmark.

Danish Medicines Agency

9-12-2009

Warning against the weight-loss product Super Slim

Warning against the weight-loss product Super Slim

The Danish Medicines Agency strongly warns against using the weight-loss product Super Slim. We do so based on a warning from the Swedish Medical Products Agency against Super Slim, which is sold on the internet.

Danish Medicines Agency

21-12-2018

Breast implant associated cancer (or BIA-ALCL)

Breast implant associated cancer (or BIA-ALCL)

Breast implant associated cancer, or breast implant associated anaplastic large cell lymphoma (BIA-ALCL), is a rare cancer of the immune system

Therapeutic Goods Administration - Australia

21-11-2018

EU/3/18/2087 (Consejo Superior de Investigaciones Cientificas (CSIC))

EU/3/18/2087 (Consejo Superior de Investigaciones Cientificas (CSIC))

EU/3/18/2087 (Active substance: Etamsylate) - Orphan designation - Commission Decision (2018)7796 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/135/18

Europe -DG Health and Food Safety

20-11-2018

.@US_FDA has updated the webpage on Urogynecologic Surgical Mesh Implants. Read more:  https://go.usa.gov/xPAzD  #MedicalDevice

.@US_FDA has updated the webpage on Urogynecologic Surgical Mesh Implants. Read more: https://go.usa.gov/xPAzD  #MedicalDevice

. @US_FDA has updated the webpage on Urogynecologic Surgical Mesh Implants. Read more: https://go.usa.gov/xPAzD  #MedicalDevice

FDA - U.S. Food and Drug Administration

14-11-2018

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or   manage pain:  https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/xPfuw  #FDA #MedicalDevice pic.twitter.com/kgDSx2PQzn

FDA - U.S. Food and Drug Administration

26-9-2018

Today, the National Breast Implant Registry opened. This new registry, a collaboration between @ASPSMembers, implant manufacturers and #FDA, provides an important new platform for evaluating real world data on the safety and performance of breast implants

Today, the National Breast Implant Registry opened. This new registry, a collaboration between @ASPSMembers, implant manufacturers and #FDA, provides an important new platform for evaluating real world data on the safety and performance of breast implants

Today, the National Breast Implant Registry opened. This new registry, a collaboration between @ASPSMembers, implant manufacturers and #FDA, provides an important new platform for evaluating real world data on the safety and performance of breast implants https://bit.ly/2OU7wKX 

FDA - U.S. Food and Drug Administration

14-9-2018

#FDA's Dr. Binita Ashar provides a statement on continuing the agency’s commitment to studying breast implant safety. To read the statement, click the link:  https://go.usa.gov/xPg4C  #MedicalDevices

#FDA's Dr. Binita Ashar provides a statement on continuing the agency’s commitment to studying breast implant safety. To read the statement, click the link: https://go.usa.gov/xPg4C  #MedicalDevices

#FDA's Dr. Binita Ashar provides a statement on continuing the agency’s commitment to studying breast implant safety. To read the statement, click the link: https://go.usa.gov/xPg4C  #MedicalDevices

FDA - U.S. Food and Drug Administration

7-9-2018

Consumer story: Georgia and breast implant associated cancer

Consumer story: Georgia and breast implant associated cancer

Learn how to spot the warning signs for breast implant associated cancer in our new consumer story

Therapeutic Goods Administration - Australia

22-7-2018

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. ht

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. ht

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. https://www.bloomberg.com/news/articles/2018-07-20/bayer-to-stop-selling-contraceptive-implant-after-threats-by-fda …

FDA - U.S. Food and Drug Administration

18-4-2018

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (Active substance: Adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1) - Orphan designation - Commission Decision (2018)2404 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/254/17

Europe -DG Health and Food Safety