8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LACTOSORB POP RIVET
FDA 510(k)
FDA Class 2
·Orthopedic
TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TINNITUS MASKER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·February 27, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 5, 2014
12X150MM KII OPTICAL ACCESS SYSTEM NON-THREADED
FDA Adverse Event
APPLIED MEDICAL·Product code GCJ·January 26, 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