8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GRAND CERAM
FDA 510(k)
FDA Class 2
·Dental
Arm Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
NAVIJECT SUB2-1P, MODEL: LP604430
FDA 510(k)
FDA Class 1
·Ophthalmic
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·Product code LZG·March 7, 2013
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·February 15, 2011
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014
HAMILTON MEDICAL AG
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·December 21, 2023
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024