10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NIL
FDA 510(k)
FDA Class 1
·Ophthalmic
SwishActive™ Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307106654·Ø3.7 x 8 Platform 3.5mmD
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690195290·AK3 Flat Insert Trial Size 1-3 - 8mm
RENAL SYSTEMS PERITONEAL ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RG27-SERIES RESECTOSCOPE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PORTEX® BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·March 28, 2017
PORTEX®BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.,·Product code JOH·June 28, 2016
CURLIN INFUSION IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·January 9, 2013
PRECISION EXTRA GLUCOMETERS
FDA Adverse Event
Malfunction
·ABBOTT·Product code NBW·December 27, 2010
ENDURANT II
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·July 18, 2014