10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DURALASTIC ANATOMICAL MALAR IMPLANTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SBI STAFIX
FDA 510(k)
FDA Class 2
·Orthopedic
NITROX 30 - ANESTHETIC GAS PROPORTIONER
FDA 510(k)
FDA Class 2
·Anesthesiology
BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 22, 2018
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·February 4, 2013
STRATA II, ADJUSTABLE DELTA VALVE, SMALL
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·January 21, 2011
LEAD MODEL UNKNOWN
FDA Adverse Event
Malfunction
·CYBERONICS·Product code LYJ·July 31, 2014
LOGIC CR TIB INSERT STD, SZ 5, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 31, 2023
SMOOTH ROUND HIGH PROFILE
FDA Adverse Event
Injury
·MENTOR MEDICAL SYSTEM B.V.·Product code FTR·May 13, 2025
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013