12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Symmetry Sharp Kerrison Rongeur
FDA 510(k)
FDA Class 2
·Neurology
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
COCHLEA-SCAN / COCHLEA-SCAN PLUS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PASSEO-18 5/200/90
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021
PASSEO-18 6/200/90
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021
BD 5ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 4, 2020
PASSEO-18 2.5/170/130
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 16, 2016
LC PCA III INFUSER
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·June 3, 2013
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·October 10, 2014
PORTEX 7.5MM CUFFED TRACHEAL TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL LTD.,·Product code JOH·May 13, 2011
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021