10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
FDA 510(k)
FDA Class 2
·Cardiovascular
NEW WEST SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
US NANCY NAIL 450 20/10
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSB·July 26, 2016
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 1, 2013
SEGURA HEMISPHERE STONE RETRIEVAL BASKET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FFL·February 16, 2011
DUODERM EXTRA THIN DRESSING
FDA Adverse Event
Malfunction
·CONVATEC, INC.·Product code NAD·July 24, 2014
SORIN AF 620 W/LOOP 10
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DWE·June 25, 2010
US NANCY NAIL 450 25/10
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HSB·June 1, 2017
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025