9 results
·
23ms
·
Sources: EU EUDAMED, US FDA
MICRO HAEMATOCRIT CENTRIFUGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QUANTUM ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TUMBLER, GENERAL MEDICAL MEDI-PAK
FDA 510(k)
FDA Class 2
·General Hospital
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·February 11, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 13, 2011
SONICFILL COMPOSITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EBF·July 28, 2014
FT3 - FREE TRIIODOTHYRONINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CDP·October 10, 2014
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024