3 results
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11ms
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Sources: EU EUDAMED, US FDA
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
REF 70-0073-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, RETRO, STRAIGHT, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in orthaepedic surgery where a cutting instrument is required.
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code HRX·January 28, 2010
High Performance Sodasorb Carbon Dioxide Absorbent, Diving Grade(18%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorber is depleted; Manufactured by: W.R. Grace & Company, 6050 West 51st Street, Chicago, IL 60638; the product is packaged in 5-gallon pails under the W.R. Grace label
FDA Recall
Terminated
·Darex Container Products Div of W.R. Grace & Co.·Product code CBL·February 11, 2003