9 results
·
24ms
·
Sources: EU EUDAMED, US FDA
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NEPHROSTOMY/BILIARY DRAINAGE BAG
FDA 510(k)
FDA Unclassified
·Unknown
PORTABLE DIAGNOSTIC LABORATORY
FDA 510(k)
FDA Class 1
·Microbiology
SONICFILL COMPOSITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EBF·July 11, 2014
SONICFILL COMPOSITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EBF·July 11, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 16, 2014
BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·December 14, 2012
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·October 14, 2010
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024