14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRO-TOE Hammertoe Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304674905·
MODIFIED CONCENTRIC RETRIEVER, MODEL 90039
FDA 510(k)
FDA Class 2
·Cardiovascular
VTS1000
FDA 510(k)
FDA Class 1
·General Hospital
PEN NDL 31G 8MM 90 COUNT MAIL ORDER ONLY
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 3, 2021
CPS TRANSVERSE PIN 6PK 32MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·October 23, 2019
CPS SM SHT SPDL W PINS 400LBF
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 23, 2019
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code NVY·June 7, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 6, 2011
CPS SHORT ANCHOR PLUG 16MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 2, 2019
CPS SM SHT SPDL W PINS 600LBF
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·August 28, 2024
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
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017