10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601
FDA 510(k)
FDA Class 2
·Radiology
AC WOUND TREATMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
BD PRESET¿ ECLIPSE¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 9, 2024
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 7, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
TELEREHAB WIRELESS CARDIAC TELEMETRY TRANSMITTER
FDA Adverse Event
Malfunction
·SCOTTCARE CORP.·Product code DSI·September 5, 2008
EQUINOXE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·December 15, 2023
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023