12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Altrix Precision Temperature Management System
FDA 510(k)
FDA Class 2
·Cardiovascular
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704283976·
Acetabular Reamers 66 mm
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215073046·
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161121522660·Bridgeback Acetabular Reamer, Size 66mm
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
ISOLED AC-POWERED LED HEADLIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·July 7, 2011
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 7, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MFG DC BOULDER·Product code GEI·March 21, 2022
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023