8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SINUSCOPE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ADIN DENTAL IMPLANTS SYSTEM
FDA 510(k)
FDA Class 2
·Dental
HemoCue Hb 801 System
FDA 510(k)
FDA Class 2
·Hematology
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·February 27, 2013
ENTERRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LNQ·August 5, 2014
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 8, 2011
ARCHITECT C16000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·May 10, 2019
Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma
FDA Recall
Terminated
·Abbott Laboratories Inc.·Product code CIX·March 10, 2010