8 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LATEX EXAMINATION GLOVE POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
MODEL 480CI INFUSION PUMP, MODIFICATION
FDA 510(k)
FDA Class 2
·General Hospital
MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON
FDA 510(k)
FDA Class 2
·Orthopedic
1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·August 22, 2018
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 11, 2014
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code DQX·February 22, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024