5 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·March 11, 2015
TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·March 11, 2015
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·October 15, 2014
Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·March 18, 2015
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·March 11, 2015