Medical Device King Investigation

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June 2, 2016: President of Pharmaceutical Companies …

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/june-2-2016-president-pharmaceutical-companies-sentenced-60-months-prison-long-running-scheme-sell

Earlier today in Central Islip, NY, William Scully, the president of Pharmalogical, Inc. (Pharmalogical) d/b/a Medical Device King and MDK, and Taranis …

Medical Device King sold imported IUDs and counterfeit cancer …

https://www.safemedicines.org/2015/11/medical-device-king-counterfeit-drugs.html

Medical Device King owners William Scully and Shahrad Rodi Lameh were recently convicted on 66 charges and ordered to pay $17 million dollars in restitution and …

Alabama Doctor Indicted for Purchasing Black Market IUDs from …

https://www.safemedicines.org/2014/06/alabama-doctor-indicted-for-purchasing-black-market-iuds-from-medical-device-king-6-16-14.html

Alabama Doctor Indicted for Purchasing Black Market IUDs from Medical Device King. Dr. Yashica Robinson-White, 38 of Opelika, Alabama is being prosecuted based on her …

DOJ Enforcement Panel Focuses on Medical Device Companies

https://www.policymed.com/2015/02/doj-enforcement-panel-focuses-on-medical-device-companies.html

DOJ HHS-OIG. By Thomas Sullivan Last updated May 5, 2018. Last week’s CBI Medical Device and Diagnostic Compliance Congress featured an “enforcement …

Frequently Asked Questions About Medical Devices

https://www.fda.gov/files/about%20fda/published/Frequently-Asked-Questions-About-Medical-Devices---Information-Sheet.pdf

Examples of medical devices include surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. A longer list of examples of …

Medical Device Complaint Handling Investigation | Oriel STAT A …

https://www.orielstat.com/blog/extent-investigate-medical-device-complaint/

Medical Device Complaint Investigation Procedure. LEVEL I: Conduct an initial investigation. Confirm the complaint. Is the alleged deficiency actually a …

Investigational Medical Devices - Hopkins Medicine

https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/devices.html

There are two categories of devices: Category A (experimental/investigational devices for which there is no Medicare coverage); and Category B (non-experimental …

IDE Responsibilities | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-responsibilities

Promote or test market an investigational device, until after FDA has approved the device for commercial distribution. Commercialize an investigational …

Clinical investigations of medical devices – guidance for …

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1097798/Information_for_clinical_investigators_-_May_2021.pdf

There must be an emergency procedure to enable immediate identification of the devices within the investigation – this may be required in the event of an immediate recall of the …

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 …

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