7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OXYGEN CANNULA EAR WRAP (STYLE B)
FDA 510(k)
FDA Class 1
·Anesthesiology
Stellar LEAP
FDA 510(k)
FDA Class 1
·Physical Medicine
CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX NOVUS LEAD MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 10, 2012
GASTRISAIL 36 FR. GASTRIC POS
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code KNT·June 23, 2015
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