7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALBG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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
HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015
FDA 510(k)
FDA Class 2
·Orthopedic
ELRA Electrode
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NBIH BIPOLAR PACING ELECTRODE CATHETER
FDA Adverse Event
C.R. BARD INC. (BEP)·Product code LDF·December 13, 2010
UNICEL® DXC 800 SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·February 27, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014