26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COSMED K5 Wearable Metabolic Technology
FDA 510(k)
FDA Class 2
·Anesthesiology
3DP Lumbar Interbody System
FDA UDI
Genesys Orthopedics Systems LLC·M719GL3DS1625150·Small 15-Degree 3DP LLIF - 16mm x 25mm
3DP Lumbar Interbody System
FDA UDI
Genesys Orthopedics Systems LLC·M719GL3DM1625150·Medium 15-Degree 3DP LLIF - 16mm x 25mm
ID NOW COVID 19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·December 2, 2021
Apache
FDA UDI
Genesys Orthopedics Systems LLC·M719GLLTIL1625150·Large 15 DEG Titanium LLIF
Apache
FDA UDI
Genesys Orthopedics Systems LLC·M719GLLTIS1625150·Small 15 DEG Titanium LLIF
Apache
FDA UDI
Genesys Orthopedics Systems LLC·M719GLLTIM1625150·Medium 15 DEG Titanium LLIF
RETENTION FLOW OPAQUE
FDA 510(k)
FDA Class 2
·Dental
NP15
FDA 510(k)
FDA Class 2
·Anesthesiology
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·June 11, 2013
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 14, 2011
KAPPA 900 DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code DXY·October 10, 2014
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
BD NANO¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 4, 2019
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 7, 2022
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
BD ULTRA FINE PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·September 11, 2020
PEN NDL 32G 4MM 5B XTW BULK US W/EXPIRY
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 13, 2020