7 results
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34ms
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Sources: EU EUDAMED, US FDA
COULTER COUNTER MODEL S-PLUS STKR
FDA 510(k)
FDA Class 2
·Hematology
POTASSIUM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TomoTherapy Treatment Delivery System with iDMS
FDA 510(k)
FDA Class 2
·Radiology
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 13, 2014
CXD II
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - LARGO·Product code KDJ·October 16, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 13, 2012
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