9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EZFLOW MAX, MODEL 1007
FDA 510(k)
FDA Class 2
·Anesthesiology
artegral life
FDA UDI
Merz Dental GmbH·D7091993558·anteriors; shade BL1; mould UBIL
LASER CANE
FDA 510(k)
FDA Class 1
·Ophthalmic
HEALICOIL Knotless Suture Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM]
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code GEI·February 26, 2014
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
UNKNOWN·Product code IKX·March 7, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
TOTALCARE BARIATRIC
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·January 24, 2011
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024