25 results
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30ms
·
Sources: EU EUDAMED, US FDA
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743724·ACHIMED ACHILLES SUPP SAND III
CTXA Hip Bone Mineral Densitometer
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DICTXAHIP0·The CTXA Hip Bone Mineral Densitometer (CTXA Hi...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450246405·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450160688·
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 2, 2025
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523123896·TLIF Trial, 13mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523146048·Tesera T, Straight Trial 28mm x 10mm x 13mm, Bu...
OMNIPORT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·August 22, 2013
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 12, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 12, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 6, 2025
ZEPHYR XL DR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·March 13, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 12, 2014
CYBERONICS-VAGUS NERVE STIMULATOR
FDA Adverse Event
Death
·CYBERONICS·Product code LYJ·February 18, 2011
SMALL BATTERY DRIVE
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·April 29, 2014
ASPIRATION TUBING
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·February 14, 2019
HOMEPUMP ECLIPSE: 400ML, 100ML/HR
FDA Adverse Event
Malfunction
·I-FLOW, LLC.·Product code MEB·February 6, 2013