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medical device

The EU’s MDR and IVDR Achieve Final Approval

The wait is nearly over for the official publication of the European Union’s (EU)...

EpiPens Recalled Due to Defective Part

Meridian Medical Technologies, the manufacturer of Mylan’s EpiPen-brand of epinephrine auto-injectors, has announced a...

Ventricular Assist Device Pumps Recalled

HeartWare is recalling its Ventricular Assist Device (HVAD) with serial numbers lower than HW25838. A design problem...

Interlogix Recalls Personal Panic Devices Due to Failure to Operate

Interlogix is recalling their wireless personal panic devices as the devices can fail to operate...

Surgical Power Tool Battery Adaptors Recalled

DePuy Synthes is recalling the Adaptor and Light Adaptor for Small Battery Drive and...
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FDA Approves Motorized Leg Braces

The U.S. Food and Drug Administration (FDA) has approved a medical device that functions...

FDA Approves “Smart” Contact Lens Medical Device

The U.S. Food and Drug Administration (FDA) has approved the marketing of a one-time...

Paralyzed Man’s Arm Wired to Receive Brain Signals

In the future, people with paralyzed limbs could have full use of their bodies...

Certification of Medical Devices in China

A Complex Process Results in Long Lead Times for Market Access Manufacturers of medical products...

FDA’s CDRH Seeking Customer Feedback

The U.S. federal agency responsible for the regulation and oversight of medical devices is...
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