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Understanding Filling in Wrinkles Safely

Safe Wrinkle Fillings By GCS (LinkedIn and Twitter) A popular treatment involves injecting dermal fillers into the face. In studies of FDA-approved dermal fillers, people generally report they are...

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Reprocessing Medical Devices in Health Care Settings

Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff Document issued on: March 17, 2015 Today, the United...

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FDA Warning to Zizion Group for Lack of PMA or 510k

FDA Warning Letter Issued to the Zizion Group LLC 3/12/15 The Food and Drug Administration (FDA) has reviewed your Internet website http://yesprpkit.com. Your website states that your Yes PRP Kit is an...

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FDA Warning to Tiller MIND BODY for Lacks of PMA or 510k

FDA Warning Letter Issued to Tiller MIND BODY, Inc.  2/25/15 During an inspection of your firm located in San Antonio, Texas on June 23, 2014 through June 26, 2014, an investigator from the United...

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FDA CDRH Announcement for Procedures for Meeting of the Advisory Committee

The Center for Devices and Radiological Health (CDRH) Food and Drug Administration (FDA)   Today, the U.S. Food and Drug Administration released a draft guidance: “Procedures for Meetings of the...

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Medical Device Approval for Use in Brain Surgery Over Stitches for Dura Repair

Adherus AutoSpray Dural Sealant – P130014 Product Name: Adherus AutoSpray Dural Sealant PMA Applicant: HyperBranch Medical Technology, Inc. Address: 800-12 Capitola Drive, Durham, North Carolina 27713...

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FDA Approves a Peripheral Stent System

FDA Class III Medical Device Approval Misago Peripheral Stent System – P140002   Product Name: Misago Peripheral Stent System Approval Date: May 22, 2015 Approval Letter:...

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FDA Approves an Emergency Use of MERS-CoV Detection Kit

US Food and Drug Administration (FDA) RealStar MERS-CoV RT-PCR Kit U.S. July 17, 2015 The FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the RealStar® MERS-CoV RT-PCR...

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