9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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troCarWash System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BONE SUPPRESSION SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
REFLECTION CONSTRAINED LINER
FDA 510(k)
FDA Class 2
·Orthopedic
PLEURX PLEURAL CATHETER MINI KIT
FDA Adverse Event
Death
·CAREFUSION·Product code DWM·September 2, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC·Product code CBK·July 18, 2013
PERSONA NATURAL TIBIA CEMENTED
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 15, 2018
PALACOS NON-ANTIBIOTIC BONE CEMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LOD·January 15, 2018
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020