8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MON-KLENZ
FDA 510(k)
FDA Class 1
·General Hospital
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122970·K-WIRE - SINGLE TROCAR 1.1mm DIA x 150mm
STERIZONE STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RENAISSANCE 26 P-WASS
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FPO·December 8, 2010
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2013
M2A-MAGNUM PF CUP 50ODX44ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 17, 2014
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026