8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EVIS 200 SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515240247·Takahashi Nasal Fcps, 4x10mm jaw
ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET;
FDA 510(k)
FDA Class 2
·General Hospital
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
FDA 510(k)
FDA Class 2
·Orthopedic
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·January 28, 2013
EB CARLENS W/CARINA HOOK
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTS·November 15, 2010
ENDEAVOR SPRINT RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·July 14, 2014
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024