28 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GE DATEX-OHMEDA AVANCE CS2
FDA 510(k)
FDA Class 2
·Anesthesiology
SOL-M™ Hypodermic Needle
FDA UDI
Sol-Millennium Medical, Inc.·00818392015157·Sterile hypodermic needles intended to inject f...
SCOTT'S SELECT K-FILES 6/pk 31mm # 25
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811231251·ENDODONTIC K-FILES (6/pack) Length: 31mm, Size:...
Bioseal Inc.
FDA UDI
BIOSEAL·00630094012315·Stockinette Tubular 3"x36" 1ply
COALESCENT U-CLIP- AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTELLIVUE MX40 PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 2, 2021
SOL-M
FDA Adverse Event
Malfunction
·SOL-MILLENNIUM MEDICAL INC·Product code FMI·May 21, 2026
ASCENSIA CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·February 8, 2006
ARROW/KONTRON KAAT II PLUS IABP
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL, INC.·Product code DSP·November 19, 1998
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 12, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 31, 2026
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·August 13, 2024
HYALGAN
FDA Adverse Event
Injury
·FIDIA FARMACEUTIC S.P.A·Product code MOZ·February 3, 2006
HEMOCHRON JR.SIGNATURE MICROCOAGULATION SYSTEM
FDA Adverse Event
Malfunction
·INTERNATIONAL TECHNIDYNE CORPORATION·Product code JPA·January 12, 2011
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·May 21, 2013
SIGMA 300 DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·June 14, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 20, 2008
RESOLUTE INTEGRITY RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·August 26, 2016
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·November 4, 2013