8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CEFPODOXIME 10 MCG, SENSI DISC
FDA 510(k)
FDA Class 2
·Microbiology
SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PREMIER CD RECHARGEABLE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ONE-STEP SUPRAPUBIC INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code KGZ·March 27, 2018
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·December 10, 2010
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 22, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 5, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021