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FDA 510(k) Clearance vs. Premarket Approval (PMA)

This post explains the difference between FDA approval and clearance for medical devices, and how this impacts the level of testing and scrutiny a device undergoes. Knowing whether a device is approved or cleared can also impact a potential lawsuit. It’s important to understand the regulatory process for medical devices to ensure your safety and legal rights.

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Melisha Valenzuela Paralegal NGRV
Managing Staff

Melisha Valenzuela

Paralegal for: Brett Vaughn Email : mvalenzuela@nighgoldenberg.com Phone : 913-800-8635 Facebook Twitter Instagram Linkedin DOWNLOAD VCARD Biography Melisha Valenzuela has 8 years of experience in personal

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Ashley Windsor Paralegal NGRV
Managing Staff

Ashley Windsor

Paralegal for: Daniel Nigh Email : awindsor@nighgoldenberg.com Phone : 850-558-1886 Facebook Twitter Instagram Linkedin DOWNLOAD VCARD Biography Ashley Windsor currently lives in the panhandle of Florida

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Halle Knutson Paralegal NGRV
Managing Staff

Halle Knutson

Firm Administrator Email : hknutson@nighgoldenberg.com Phone : 612-424-9900 Facebook Twitter Instagram Linkedin DOWNLOAD VCARD Biography Halle Knutson grew up in a small town in Wisconsin.

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Melanie Frenz Paralegal NGRV
Managing Staff

Melanie Frenz

Paralegal for: Ashleigh Raso Email : mfrenz@nighgoldenberg.com Phone : 612-416-0044 Facebook Twitter Instagram Linkedin DOWNLOAD VCARD Biography Melanie lives in Minneapolis. She loves the outdoors and

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Valsartan Lawsuit
Active Cases

Valsartan Lawsuit

Valsartan Cancer Lawsuit – MDL 2875 Valsartan is a common drug for treating high blood pressure and heart disease. Valsartan was sold under the brand

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Tepezza Hearing Loss Lawsuit
Active Cases

Tepezza Lawsuit

Tepezza Hearing Loss Lawsuit Tepezza (teprotumumab) is manufactured by Horizon Therapeutics, Inc. Tepezza was approved by the FDA for the treatment of thyroid eye disease in January of

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Recalled Exactech Knee
Active Cases

Exactech Knee Recall Lawsuit

Recalled Exactech Knee Lawsuit Exactech recalled 147,732 Exactech artificial knee implants on August 31, 2021, which has already led to hundreds of Exactech recall lawsuits

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