54 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
FDA 510(k)
FDA Class 2
·Radiology
INNOVA IGS 530
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS SCS·Product code OWB·August 2, 2019
ZenFlex
FDA UDI
Kerr Corporation·00195062029707·Rotary Files
Origin Hip Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051792·
Origin Lateral Offset Collared Hip Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215017804·
Paxeon Origin
FDA UDI
PAXEON RECONSTRUCTION LLC·08177570205028·
ELI 250 ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STRATUS Stem - High Offset - Collared - Size 14
FDA UDI
AMPLITUDE SAS·03701089504942·
ARTIS ZEE III CEILING
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·May 17, 2024
ARTIS ZEE III CEILING
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·December 3, 2024
ARTIS Q ZEEGO
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·September 29, 2025
ARTIS ZEE III CEILING
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·April 29, 2026
ARTIS ZEE III CEILING
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·April 1, 2026
ARTIS ZEEGO III (CHINA)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·December 26, 2023
UNKNOWN DEPUY RESPONSE FEMORAL HIP STEM
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWY·June 21, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·July 21, 2011
VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code GEI·September 24, 2008
ARTIS ZEE III CEILING
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·October 28, 2025
PRONTO SPOT CHECK PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 9, 2018