7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIBERTY LITE PFS SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CUP, DISPOSABLE SPECIMEN
FDA 510(k)
FDA Class 1
·Pathology
Reprocessed Inquiry Steerable Diagnostic EP Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
FDA Adverse Event
Malfunction
·REYNOSA MFG·Product code FKX·January 25, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 28, 2014
ACCU-CHEK ® COMPACT PLUS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·January 13, 2011
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024