7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·June 10, 2014
CHLORAPREP ONE -STEP FREPP 1.5 ML
FDA Adverse Event
Malfunction
·CAREFUSION·Product code KXF·October 4, 2010
20'" CENTURY STERILIZER
FDA Adverse Event
STERIS MEXICO, S. DE R.L. DE C.V.·Product code FLE·December 10, 2012
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022