10 results
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49ms
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Sources: EU EUDAMED, US FDA
SWISSRAY Medical, AG
FDA registration
SWISSRAY Medical, AG·3 products·🇨🇭 Switzerland
ddR Formula Plus
FDA UDI
Swissray Medical AG·00860011334620·Stationary Xray System
ddR Element
FDA UDI
Swissray Medical AG·00860011334613·Stationary Xray System
ddR Cruze
FDA UDI
Swissray Medical AG·00860011334606·Digital Mobile Diagnostic Xray System
ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
FDA Recall
Open, Classified
·Swissray Medical Hohenrainstrasse 61 Hochdorf Switzerland·Product code KPR·November 18, 2016
ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
FDA Recall
Open, Classified
·Swissray Medical Hohenrainstrasse 61 Hochdorf Switzerland·Product code KPR·August 9, 2016
DDRCOMBI PLUS
FDA Adverse Event
Injury
·SWISSRAY MEDICAL AG·Product code MQB·April 9, 2014
SYSTEM, X-RAY, STATIONARY
FDA Adverse Event
Malfunction
·SWISSRAY MEDICAL AG·Product code KPR·July 8, 2024
ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in orthopedics and trauma as well as pulmonary imaging.
FDA Recall
Terminated
·Swissray Medical AG Turbistrasse 25-27 Hochdorf Switzerland·Product code MQB·November 14, 2018
ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in orthopedics and trauma as well as pulmonary imaging.
FDA Enforcement
Class II
·Terminated·Swissray Medical AG·January 16, 2019