Unlawfully importing, distributing, or selling unapproved medical devices can lead to the seizure of goods, as well as civil penalties including fines ranging from thousands to millions of dollars ...

“From the FDA perspective, with few exceptions, healthcare professionals generally may choose to prescribe or use a legally marketed human drug or medical device for an unapproved or uncleared ...

The recall of unauthorized syringes addresses potential safety risks associated with unapproved medical devices. By removing these products from the market, the FDA safeguards patients from ...

Large medical device maker Teleflex is shuttering a Maple Grove facility and laying off 101 employees. The company, headquartered in Wayne, Pa., is stopping all operations at its facility at Sycamore ...

The U.S. Food and Drug Administration (FDA) has issued a warning to patients and healthcare professionals regarding the use ...

PETALING JAYA: Unregistered medical devices such as condoms and contact ... Consultant urologist and clinical Assoc Prof Dr George Lee said unapproved condoms are among the items commonly found ...

The LifeVac website contains a "Hall of Saves" presenting thousands of cases in which the device has saved a child or adult from choking, as well as a page devoted to medical journal articles ...