ClearanceBrief
Company ยท US

Arjo Hospital Equipment AB

FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2009. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
IKZBed, Patient Rotation, Powered3
FNLBed, Ac-Powered Adjustable Hospital1
IKYMattress, Flotation Therapy, Non-Powered1
ILJBath, Hydro-Massage1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Apr 8, 2009K082951IMMERSION HYDROBATH
Arjo Hospital Equipment AB
ILJ

Latest recalls

DateFirm and productCodeLinked 510(k)
Mar 6, 2015Arjo Hospital Equipment AB
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.
Terminated
IKYNone listed
Feb 27, 2015Arjo Hospital Equipment AB
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, immobil
Terminated
IKZNone listed
Feb 27, 2015Arjo Hospital Equipment AB
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
Terminated
IKZNone listed
Feb 27, 2015Arjo Hospital Equipment AB
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
Terminated
IKZNone listed
Oct 6, 2014Arjo Hospital Equipment AB
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
Terminated
FNLNone listed
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