7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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N LATEX STFR REAGENT
FDA 510(k)
FDA Class 2
·Immunology
uMR 780, uMR 790
FDA 510(k)
FDA Class 2
·Radiology
GLUCO LAB AUTO CODING, MODEL IGM-0022
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTIVA
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code MHY·March 6, 2013
VIRTUOSO II VR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·February 15, 2011
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·August 8, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024