7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800
FDA 510(k)
FDA Class 1
·Microbiology
SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MSTAR MPD4500
FDA 510(k)
FDA Class 2
·Radiology
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·February 22, 2013
DEHP FREE SOL ADMIN SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·January 30, 2011
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 1, 2014
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025