9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PLS PORTABLE LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450217108·
4091829
FDA Adverse Event
Malfunction
·July 15, 2014
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MINIMED PARADIGM INSULIN PUMP, MODEL 511
FDA 510(k)
FDA Class 2
·General Hospital
A5 ANESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code BSZ·April 30, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 17, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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