7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
VARELISA HELICOBACTER PYLORI ANTIBODIES
FDA 510(k)
FDA Class 1
·Microbiology
SYVA EMIT II PROPOXYPHENE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SYSTEM 3000 ELECTRONIC INSUFFLATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
12FR X 13CM TRIPLE MAH CE, TRAY
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MSD·November 30, 2010
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·February 1, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2014
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026