9 results
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26ms
·
Sources: EU EUDAMED, US FDA
LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES
FDA 510(k)
FDA Class 2
·Dental
HALO MOLAR BAND
FDA UDI
Ortho Arch Company Inc·D9099019411·U6L HALO MOLAR BAND .022 SGL CV -14T BT
LINER: MPACT FLAT PE HC LINER Ø36/G
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·March 12, 2020
SYNTHES MODULAR FOOT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
S-ICD SYSTEM
FDA Adverse Event
Malfunction
·CAMERON HEALTH INC·Product code NVY·May 7, 2014
UNK DEEP BRAIN STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·November 12, 2010
TOTALCARE BARIATRIC
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 21, 2012
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015