8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BARDEX I.C. PEDIATRIC FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
artegral life
FDA UDI
Merz Dental GmbH·D7091993464·anteriors; shade D3; mould CS
ND:YAG Laser
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RAPIDSORB PLUS SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Dental
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·March 7, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·February 8, 2011
MONACO RTP SYSTEM
FDA Adverse Event
IMPAC MEDICAL SYSTEMS, INC.·Product code MUJ·July 25, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021