Earl Elmer Bakken was an American engineer, inventor, businessman and philanthropist. He founded Medtronic, where he developed the first external, battery-operated, transistorized, wearable artificial
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved
Earl Bakken
…astonishment, when he came in the next day, he found the pacemaker already in use on a patient. (The Food and Drug Administration did not start regulating medical devices until 1976.) Over the next several years, Bakken and Medtronic worked with other doctors to develop fully implantable pacemakers, but they also veered…
Tongue depressor, a Class I medical device in the United States
Infusion pump, a Class II medical device in the United States
Artificial pacemaker, a Class III device in the United States
Medical devices were used for surgery in ancient Rome.