8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALBUMIN TEST RID KIT
FDA 510(k)
FDA Class 2
·Immunology
LEXINGTON MEM W COLUMBIA SC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·October 30, 2013
ANTIMICROBIAL SUSCEPT. TEST PANEL (CEFTIZOXIME)
FDA 510(k)
FDA Class 2
·Microbiology
VIDENT IMPAC IMPLANT ACCESSORIES
FDA 510(k)
FDA Class 2
·Dental
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·January 14, 2013
ON-Q PAINBUSTER
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·November 18, 2010
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·July 3, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024