9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PROCEL BURN COVER/PROCEL BURN TREATMENT COVER
FDA 510(k)
FDA Unclassified
·Unknown
MIMIX MP BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Neurology
BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·January 21, 2013
COULTER® 4C® PLUS CELL CONTROL
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JPK·December 31, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 18, 2014
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 26, 2025
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 5, 2019
M2A-MAGNUM PF CUP 52ODX46ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 5, 2019