8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MCCONNELL ORTHOPEDIC ANKLE POSITIONER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Lacrimal Chisel
FDA UDI
KATENA PRODUCTS, INC.·00841668108581·WEST LACRIMAL CHISEL STRAIGHT
TOTAL BILIRUBIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Stryker Consolidated Operating Room Equipment (CORE) 2 Console
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·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