7 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXACTECH CERAMIC FEMORAL HEAD COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
ABUSCREEN ONLINE FOR THC (50 AND 100)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PNEU-WAVE
FDA 510(k)
FDA Class 2
·Physical Medicine
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·January 14, 2013
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 3, 2010
PROMOTE PLUS CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·July 3, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024