7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AILEE SUTURES AND AILEE NEEDLES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Vitreq disposable laser probes, light fibers and Chandelier
FDA 510(k)
FDA Class 2
·Ophthalmic
OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 28, 2013
SYBRONPRO TL
FDA Adverse Event
Injury
·EBI INC.·Product code DZE·February 9, 2011
RADIESSE DERMAL FILLER
FDA Adverse Event
Other
·MERZ NORTH AMERICA, INC.·Product code LMH·July 25, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024