FDA Issues Warning Letter to Manufacturer of Defibrillator Batteries
The Food and Drug Administration (FDA) recently issued a warning to Amco International Manufacturing & Design, a producer of batteries for Automated External Defibrillators (AEDs) used in devices distributed by prominent companies like Philips, Stryker, and Zoll. This warning stemmed from Amco’s continued distribution of these batteries without obtaining the required premarket approval (PMA), a […]