8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VENTILATION TUBES W/ HYDROGEL COATING
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111079·SILICONE MAT FOR K 9-2330
CIQ CONTROLLER, CIQ WANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYDNEY IVF HYALURONIDASE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·January 22, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 13, 2010
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015