8 results
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25ms
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Sources: EU EUDAMED, US FDA
CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TC electrode
FDA UDI
Radiometer Medical ApS·05700699456557·E5260 Single pCO2 electrode
STABILITY FEMORAL PROSTHESIS W/HAP
FDA 510(k)
FDA Class 2
·Orthopedic
NONABSORBABLE POLYPROPYLENE SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADAPTER SLEEVES 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 6, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 4, 2011
LINK TWIST DRILL
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY·Product code HTW·July 17, 2014
TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).
FDA Recall
Terminated
·Radiometer America Inc·Product code LKD·September 27, 2011