7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COFIED MODULAR SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COULTER DART ALT (GPT) REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS
FDA 510(k)
FDA Unclassified
·Unknown
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 11, 2013
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011
LTV
FDA Adverse Event
Injury
·CAREFUSION 203, INC·Product code CBK·July 24, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024