HALO 360 ENERGY GENERATOR

Glavna informacija

  • Trgovački naziv:
  • HALO 360 ENERGY GENERATOR I HALO 90 ENERGY GENERATOR
  • Razred:
  • IIb
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • Medicinski uređaj
  • Proizveden od:
  • Barrx Medical Inc., SAD

Dokument

  • za javnost:
  • Informativni letak za ovaj proizvod trenutno nije dostupan, možete poslati zahtjev na našu službu za korisnike, a mi ćemo vas obavijestiti čim smo u mogućnosti da ga dobiju.


    Zatražite informativni letak za javnost.

Lokalizacija

  • Na raspolaganju u:
  • HALO 360 ENERGY GENERATOR I HALO 90 ENERGY GENERATOR
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • generator RF energije za primarnu ablaciju jednjaka

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • 381-09-4261
  • Datum autorizacije:
  • 29-04-2009
  • Zadnje ažuriranje:
  • 05-06-2018
  • Informativni letak za ovaj proizvod trenutno nije dostupan, možete poslati zahtjev na našu službu za korisnike, a mi ćemo vas obavijestiti čim smo u mogućnosti da ga dobiju.

    Zatražite informativni letak za javnost.

16-11-2018

Unauthorized "21st Century DHEA" health product seized from Moose Jaw, SK, store is labelled to contain a controlled substance and may pose serious health risks

Unauthorized "21st Century DHEA" health product seized from Moose Jaw, SK, store is labelled to contain a controlled substance and may pose serious health risks

Health Canada seized “21st Century DHEA” because it is labelled to contain dehydroepiandrosterone (DHEA), a controlled substance that may pose serious health risks. “21st Century DHEA “ is an unauthorized health product promoted to provide “support for the immune system, mental well-being & energy levels.”

Health Canada

14-11-2018

“Vita-X Revitalizing Capsules” for men may pose serious health risks

“Vita-X Revitalizing Capsules” for men may pose serious health risks

Health Canada is advising Canadians that two versions of “Vita-X Revitalizing Capsules” by Lanlay Healthmetic Inc., promoted for “long lasting vital energy for men,” may pose serious health risks. One version contains seven capsules and has “NPN 80053009,” a Natural Product Number (NPN) indicating Health Canada authorization, on the label. The second version contains one capsule, has no NPN on the label and is not authorized by Health Canada.

Health Canada

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health on the National Toxicology Program’s report on radiofrequency energy exposure

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health on the National Toxicology Program’s report on radiofrequency energy exposure

Statement from Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on the recent National Toxicology Program report release on radiofrequency energy exposure

FDA - U.S. Food and Drug Administration

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

19-6-2018

Meltz – Instant Energy For Males tablets

Meltz – Instant Energy For Males tablets

Meltz Instant Energy For Males tablets pose a serious risk to your health and should not be taken.

Therapeutic Goods Administration - Australia

6-6-2018

FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act

FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act

FDA’s Anna Abram’s testimony for U.S. House Committee on Energy and Commerce Subcommittee on Health on the Pandemic and All-Hazards Preparedness Act

FDA - U.S. Food and Drug Administration

29-5-2018

Pious Lion Voluntary Recall Due to Possible Health Risk

Pious Lion Voluntary Recall Due to Possible Health Risk

Pious Lion located in Asheville, NC is voluntarily recalling two of their Kratom products: Pious Lion Pure Premium Potent Limited Release Pink Bali, 1 oz and Pious Lion Pure Premium Potent White Maeng DA, Bright Uplifting Energy, 4 oz due to the presence of Salmonella . Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhe...

FDA - U.S. Food and Drug Administration

15-5-2018

Orphan designation:  Melatonin,  for the: Treatment of neonatal encephalopathy

Orphan designation: Melatonin, for the: Treatment of neonatal encephalopathy

Europe - EMA - European Medicines Agency

15-5-2018

Public Notification: Best Candy contains hidden drug ingredient

Public Notification: Best Candy contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Best Candy, a product promoted as an energy booster on various websites and possibly in some retail stores. This product was identified during an examination of imported goods.

FDA - U.S. Food and Drug Administration

22-2-2012

Decision on general conditional reimbursement for alendronate-containing medicines

Decision on general conditional reimbursement for alendronate-containing medicines

In cooperation with the Reimbursement Committee, we have decided to grant alendronate-containing medicines general conditional reimbursement from 5 March 2012. Reimbursement is conditional as it is reserved for patients with low-energy hip fractures. For any other patients who are treated with alendronate, the doctor must apply for single reimbursement, and the guiding criteria for single reimbursement remain unchanged for these patients. Alendronate is used for the treatment of osteoporosis (brittle bon...

Danish Medicines Agency

10-10-2018

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device:  https://go.usa.gov/xPjau pic.twitter.com/SLxGKzIIgc

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau pic.twitter.com/SLxGKzIIgc

If you use a #MedicalDevice affected by a power outage caused by #HurricaneMichael, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau  pic.twitter.com/SLxGKzIIgc

FDA - U.S. Food and Drug Administration

24-9-2018

If you use a #MedicalDevice affected by a power outage caused by #HurricaneFlorence, check out the #FDA’s tips for using a generator to restore power to your device:  https://go.usa.gov/xPjau pic.twitter.com/z8SW2mlb86

If you use a #MedicalDevice affected by a power outage caused by #HurricaneFlorence, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau pic.twitter.com/z8SW2mlb86

If you use a #MedicalDevice affected by a power outage caused by #HurricaneFlorence, check out the #FDA’s tips for using a generator to restore power to your device: https://go.usa.gov/xPjau  pic.twitter.com/z8SW2mlb86

FDA - U.S. Food and Drug Administration

24-8-2018

#OnePairTakeCare https://twitter.com/CDCgov/status/1032656962389913600 …

#OnePairTakeCare https://twitter.com/CDCgov/status/1032656962389913600 …

#OnePairTakeCare https://twitter.com/CDCgov/status/1032656962389913600 …

FDA - U.S. Food and Drug Administration

30-7-2018

#FDA Warns Against Use of Energy-Based Devices to Perform Vaginal “Rejuvenation” or Vaginal Cosmetic Procedures  http://go.usa.gov/xUdgB  #MedicalDevice

#FDA Warns Against Use of Energy-Based Devices to Perform Vaginal “Rejuvenation” or Vaginal Cosmetic Procedures http://go.usa.gov/xUdgB  #MedicalDevice

#FDA Warns Against Use of Energy-Based Devices to Perform Vaginal “Rejuvenation” or Vaginal Cosmetic Procedures http://go.usa.gov/xUdgB  #MedicalDevice

FDA - U.S. Food and Drug Administration