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Historical Information: FDA Issues Letters to Doctors

    https://www.fda.gov/drugs/drug-supply-chain-integrity/historical-information-fda-issues-letters-doctors-who-may-have-purchased-counterfeit-or-unapproved
    On May 13, 2013, FDA sent more than 1,000 letters to medical practices that may have received prescription drugs from Pharmalogical, Inc., d/b/a Medical Device …

Dermal Fillers (Soft Tissue Fillers) | FDA

    https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/dermal-fillers-soft-tissue-fillers
    Dermal fillers, also known as injectable implants, soft tissue fillers, lip and facial fillers, or wrinkle fillers are medical device implants approved by the FDA for use in helping to …

OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic ...

    https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/onabotulinumtoxina-marketed-botoxbotox-cosmetic-abobotulinumtoxina-marketed-dysport-and
    OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc) Information | FDA …

Special Report - 'Botox Police': FDA crime unit draws fire

    https://www.reuters.com/article/us-usa-fda-cases-specialreport-idUSKCN11E1Y0
    Some FDA agents complain they have turned into the “Botox Police” – chasing down every doctor who purchased authentic versions of the popular anti-wrinkle …

Botox (onabotulinumtoxinA) FDA Approval History

    https://www.drugs.com/history/botox.html
    Botox (onabotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the treatment of overactive bladder, urinary …

Counterfeit Version of Botox Found in the United States

    https://www.fda.gov/drugs/drug-safety-and-availability/counterfeit-version-botox-found-united-states
    [4-16-2015] FDA is alerting health care practitioners and the public that a counterfeit version of Botox was found in the United States and may have been sold to doctors’ offices and …

Medical Devices | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/Medical-Devices
    Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in Software as a Medical Device (SaMD), Interoperability Science and Research CDRH research …

King Brand BFST Information

    https://www.kingbrand.com/BFST-Home.php
    King Brand ® ColdCure ® and BFST ® Wraps are FDA Registered medical devices. They have also passed the Health Canada, ISO 13485, ISO 10993 and IEC 60601-1 3rd Edition approval processes. ISO 10993 in particular …

6/27/2013 List of Doctors or Clinics Purchasing from …

    https://www.fda.gov/media/128566/download
    6/27/2013 List of Doctors or Clinics Purchasing from Medical Device King That Received 5/13/2013 Letter from FDA

Importing Medical Devices | FDA

    https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices
    The FDA defines a medical device as: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a …



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