10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CADD ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
NICO Myriad NOVUS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODEL 33DA HEARING AIDS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
STERRAD 100S STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 8, 2006
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·March 6, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·January 28, 2011
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
COD.712 TOP CIRC.RACC.CARDIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTN·December 15, 2011
STERRAD 100NX STERILIZER 1-DR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·January 6, 2021
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020