26 results · 22ms · Sources: EU EUDAMED, 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