7 results
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25ms
·
Sources: EU EUDAMED, US FDA
WILTEK BALLOON STONE EXTRACTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SECURLINE SURGICAL SKIN MARKER 1000
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5
FDA 510(k)
FDA Class 2
·Immunology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·June 25, 2014
SITTER II
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·November 5, 2010
LAMITRODE TRIPOLE 8
FDA Adverse Event
Injury
·ST. JUDE MEDICLA - NEUROMODULATION·Product code LGW·December 20, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024