10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BERKELEY FORK
FDA 510(k)
FDA Class 1
·Physical Medicine
VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYNERGY
FDA 510(k)
FDA Class 2
·Dental
TRABECULAR METAL REVERSE SHOULDER HUMERAL STEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSD·November 1, 2016
TRABECULAR METAL REVERSE SHOULDER POLY LINER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSD·November 1, 2016
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 21, 2014
ENDOPATH XCEL BLUNT TIP TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GCJ·November 30, 2007
APOGEE SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 29, 2012
INVERS/REVERS SCR SYST 4.5-36
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code PHX·May 14, 2025
15MM POST LENGTH BASE PLATE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·April 18, 2025