8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TNI softFlow 50
FDA 510(k)
FDA Class 2
·Anesthesiology
All Poly Monotrial UC
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215081317·
PHILIPS INTELLIVUE TCG10
FDA 510(k)
FDA Class 2
·Anesthesiology
QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 27, 2011
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
BIOCOR STENTED PORCINE HEART VALVE
FDA Adverse Event
Injury
·ST JUDE MEDICAL BRASIL LTDA.·Product code LWR·September 26, 2008
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024