8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
FDA 510(k)
FDA Class 2
·Dental
Clarius Ultrasound Scanner
FDA 510(k)
FDA Class 2
·Radiology
ATLAS-BASED AUTOSEGMENTATION
FDA 510(k)
FDA Class 2
·Radiology
PRIMUS
FDA Adverse Event
Death
·DRAEGER MEDICAL GMBH·Product code BSZ·February 22, 2013
LINEAGE(R) TRANSCEND(R) CERAMIC ACETABULAR LINER
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code MRA·February 7, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·July 24, 2014
1.85MM TI MATRIX SCREW SELF-TAPPING/4MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·January 21, 2015
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024