7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLUOROspeed
FDA 510(k)
FDA Class 2
·Radiology
CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL
FDA 510(k)
FDA Class 2
·Radiology
OCCLUSION BALLOON CATHETER MODEL OBC
FDA 510(k)
FDA Class 2
·Cardiovascular
VASOVIEW 7XB ENDOSCOPIC VESSEL HARVESTING SYSTEM
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code GCJ·October 1, 2008
COULTER® LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 27, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 4, 2011
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024