8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
FDA 510(k)
FDA Class 2
·Cardiovascular
GAMMA LOCKING NAIL MODIFICATION
FDA 510(k)
FDA Class 2
·Orthopedic
APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES
FDA Adverse Event
Injury
·3M UNITEK·Product code DYH·May 9, 2012
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 19, 2014
COMPOUNDERS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code NEP·February 6, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·January 4, 2011
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