7 results
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18ms
·
Sources: EU EUDAMED, US FDA
VIS-1000 VIDEO SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DIRECT CREATININE PROCEDURE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Safety Winged Blood Collection Sets
FDA 510(k)
FDA Class 2
·General Hospital
INTERSTIM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·June 2, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 26, 2012
COMBI SET
FDA Adverse Event
Injury
·REYNOSA MANUFACTURING·Product code FJK·September 21, 2010
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