15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FS-500DDR Medical Radiographic X-Ray System
FDA 510(k)
FDA Class 2
·Radiology
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575316229·Rotational Knee Joint Prosthesis,Femoral component
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575316212·Rotational Knee Joint Prosthesis,Femoral component
BD SAFETY-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·November 26, 2023
BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 23, 2023
NEEDLE SFTYGLD 23X1 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·November 21, 2023
FD TENS 2030, MODEL DFJ24T
FDA 510(k)
FDA Class 2
·Neurology
EZONO 3000
FDA 510(k)
FDA Class 2
·Radiology
BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 11, 2023
XPO W/SUPPLEMENTAL BATTERY 9153648167
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 5, 2015
BD SAFETY-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·October 29, 2023
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 8, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 8, 2013
FREESTYLE LITE
FDA Adverse Event
Injury
·Product code NBW·July 7, 2011
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023