8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Inset Reverse Total Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252221200·ceraMotion® Me Chroma Concept Opaque 1, bleach,...
AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
VX650
FDA 510(k)
FDA Class 2
·Ophthalmic
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 14, 2014
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER (AU5431-02)
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMAK.K.·Product code JJE·September 16, 2011
WAVELIGHT FS200 FEMTOSECOND LASER
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code GEX·July 25, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024