11 results
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20ms
·
Sources: EU EUDAMED, US FDA
MILENIA(TM) FSH (MKFS1,5)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756120319·STANDARD BASIN SET
Arthrex
FDA UDI
Provision·B504OMAR8950050·
Arthrex®
FDA UDI
ARTHREX, INC.·00888867054394·DRILL BIT, 3.0MM
FIBER MESH
FDA 510(k)
FDA Class 2
·Dental
BROOKER ACETABULAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex®
FDA UDI
ARTHREX, INC.·00888867272699·3.0MM DRILL BIT, REUSABLE
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 25, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·January 3, 2013
PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO S DE RL DE CV·Product code FPO·November 2, 2010
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014