15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
FDA 510(k)
FDA Class 2
·Orthopedic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138272·Trial, 42 X 32, 19mm Height 28° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138289·Trial, 42 X 32, 21mm Height 28° Hyperlordotic
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523138265·Trial, 42 X 32, 17mm Height 28° Hyperlordotic
URYXXON RELAX URINE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DOUBLE MOBILITY HC LINER 28/DMD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·December 2, 2016
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025
AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE 1
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 12, 2019
PROTECTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 10, 2014
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·July 8, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013
MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·January 4, 2017
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025
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