7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS
FDA 510(k)
FDA Class 2
·Ophthalmic
CRYSTALLINE BONE SCREW ENDO-OSSEOUS
FDA 510(k)
FDA Class 2
·Dental
SKIASCOPIC RACKS
FDA 510(k)
FDA Class 1
·Ophthalmic
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·October 11, 2010
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·December 14, 2012
AVANCE
FDA Adverse Event
Malfunction
·DATEX-OHMEDA·Product code BSZ·April 18, 2014
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