10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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syngo.via MI Workflows VB40A, Scenium
FDA 510(k)
FDA Class 2
·Radiology
Bernafon
FDA UDI
Bernafon AG·05711584086346·ZR1 MNR T, 2.4G NFM DPB SABE/MSIL ZERENA 1
ARSENAL PETITE LAPIDUS PLATE, R
FDA Adverse Event
Injury
·TRILLIANT SURGICAL·Product code HRS·April 3, 2020
REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX
FDA 510(k)
FDA Class 2
·Orthopedic
EXELINT ALUMINUM HUB BLUNT NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
UNKNOWN CATHETER
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·October 14, 2016
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 28, 2011
S-ROM*LINR LSER,10 DEG,22.225
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC·Product code KWA·June 26, 2013
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 26, 2008
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018