11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DR 600
FDA 510(k)
FDA Class 2
·Radiology
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
SL3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
APOLLO GENERATOR
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code GWG·June 11, 2015
POLYMOBIL PLUS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code IZL·February 24, 2026
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·June 5, 2013
STARDRIVE SCREWDRIVER SHAFT T8 105MM
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code KWQ·September 27, 2016
MOBILETT ELARA MAX
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE GMBH·Product code IZL·December 18, 2020
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