7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ARROW FWD POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Cepheid Xpert SA Nasal Complete Control Panel
FDA 510(k)
FDA Class 2
·Microbiology
ARCOS CONE PROXIMAL BODY SZ B STD 60MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·March 6, 2013
CAPSURE SENSE
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·August 8, 2014
CRYSTALENS HD
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code NAA·February 7, 2011
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