8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BUSSE EPIDURAL CATHETER KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
DEPTH GAUGE FOR 3.5MM CORTEX SCREWS
FDA Adverse Event
Malfunction
·SYNTHES JENNERSVILLE·Product code HTJ·March 8, 2013
ESSURE
FDA Adverse Event
Malfunction
·BAYER PHARMA AG·Product code HHS·July 24, 2014
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 13, 2011
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020