7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)
FDA 510(k)
FDA Class 2
·Ophthalmic
SPECTACLE, MAGNIFYING
FDA 510(k)
FDA Class 1
·Ophthalmic
Remedy Acetabular Cup
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN ENDO STITCH INSTRUMENT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL·Product code KOG·February 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·January 18, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 1, 2014
IMMAGE Immunochemistry Systems Wash Solution Part Number: 447060 The IMMAGE Immunochemistry Systems Wash Solution is intended for use with IMMAGE Immunochemistry Systems and reagents for the quantitative determinations of components in biological fluids. The Beckman Coulter IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top analyzer designed for the in vitro quantitation of biological fluid components and therapeutic drugs. The system methodologies are rate turbidimetry and rate nephelometry.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LDT·August 24, 2010