9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DR. FOG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Walgreens
FDA UDI
WALGREEN CO.·00311917182957·Transparent Waterproof Dressings,all one size, ...
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668103050·BADAWY FEMTO SPLITTER, LEFT
LARYNGOTELESCOPE CURVED MLC-1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
THERMASSAGE ENERGY PRODUCT, MODEL HY5000
FDA 510(k)
FDA Class 2
·Physical Medicine
PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·January 24, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 17, 2010
LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 14, 2014
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
FDA Enforcement
Class I
·Terminated·BioMedical Equipment Service Co (BMES)·August 18, 2021