8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PathLoc SI Joint Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
SPACER G TEMPORARY HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
MODULAR HEAD COMPONENT 28MM DIAMETER MINUS 6 NECK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·September 1, 2011
BATTERY 14.8V, 6.3 AH LI-ION BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 15, 2014
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·July 12, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024