15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FilmArray Pneumonia/Pneumoniaplus Control
FDA 510(k)
FDA Class 2
·Microbiology
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319741351·Day Ear Hook 6-1/2" (16.5cm), large size
STRAUMANN DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PIONEER LUMBAR PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·March 18, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 19, 2025
6000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
DA VINCI SURGICAL ROBOT
FDA Adverse Event
Injury
·Product code NAY·October 15, 2014
BIO CONSOLE 560
FDA Adverse Event
Malfunction
·PERFUSION SYSTEMS·Product code DWA·November 4, 2025
Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 1, 2020
BIO CONSOLE 560
FDA Adverse Event
Malfunction
·PERFUSION SYSTEMS·Product code DWA·December 8, 2025
BIO CONSOLE 560
FDA Adverse Event
Malfunction
·PERFUSION SYSTEMS·Product code DWA·December 8, 2025
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022