8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MODIFIED VOLUMETRIC INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
XPLAN 2.2 WITH THE BODY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DRILL F.RADIOLUCENT TARGETING DEVICE SIDEWINDER Ø3,2 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-KIEL·Product code LXH·September 16, 2013
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·January 14, 2013
KNIFE
FDA Adverse Event
Malfunction
·ALCON PRECISION DEVICE·Product code HNN·November 12, 2010
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD·Product code INM·July 3, 2014
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021