8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RayStation
FDA 510(k)
FDA Class 2
·Radiology
KAINOS+
FDA 510(k)
FDA Class 2
·Orthopedic
RAYSTATION
FDA 510(k)
FDA Class 2
·Radiology
NOVOSTITCH PRO MEN RPR SYS 2-0
FDA Adverse Event
Injury
·CETERIX ORTHOPAEDICS, INC·Product code GAT·May 6, 2021
PINNACLE MTL INS NEUT36IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·October 21, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·August 4, 2011
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·June 21, 2013
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