14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module
FDA 510(k)
FDA Class 2
·Cardiovascular
SA Repl. Cvr. (1Hr) 10-Pk, VelaShape II
FDA UDI
SYNERON MEDICAL LTD·37290109950359·SA Repl. Cvr. (1Hr) 10-Pk, VelaShape II
VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR
FDA 510(k)
FDA Class 2
·Radiology
LIFESYNC ADAPTER, MODEL LS-302
FDA 510(k)
FDA Class 2
·Cardiovascular
BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·March 20, 2023
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·June 17, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
ACCU-CHEK ® ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 15, 2014
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·October 4, 2024
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·October 9, 2019
BD LUER-LOK¿ SYRINGE PHARMACY CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·May 18, 2023
BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·March 20, 2023
PEDICLE SCREW 6X45
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWP·July 5, 2019
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021