9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES
FDA 510(k)
FDA Class 2
·Radiology
QUICKIE S646
FDA Adverse Event
Malfunction
·SUNRISE MEDICAL (US) LLC·Product code ITI·August 13, 2021
NEUROVISION MEDICAL MOTION SENSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·January 28, 2013
COMBISET WITH BVM
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FJK·November 22, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 12, 2014
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020