14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FACIAL SPA
FDA 510(k)
FDA Class 2
·Neurology
VITEK GRAM NEGATIVE GATIFLOXACIN
FDA 510(k)
FDA Class 2
·Microbiology
NUTRILINE
FDA Adverse Event
Malfunction
·VYGON USA·Product code LJS·July 11, 2022
NUTRILINE
FDA Adverse Event
Malfunction
·VYGON USA·Product code LJS·July 11, 2022
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 30, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 29, 2013
QUATRRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 29, 2014
ETHICON
FDA Adverse Event
Malfunction
·ETHICON J & J·Product code GCJ·June 10, 2011
BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 5 ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 22, 2022
NUTRILINE
FDA Adverse Event
Malfunction
·VYGON USA·Product code LJS·July 11, 2022
NUTRILINE
FDA Adverse Event
Malfunction
·VYGON USA·Product code LJS·August 16, 2022
NUTRILINE
FDA Adverse Event
Malfunction
·VYGON USA·Product code LJS·August 12, 2022
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015