116 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALKALINE PHOSPHATASE KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111109·INSTRUMENT CASE DOUBLE ALUMINUM
KCI NPWT GAUZE DRESSING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO GELBFISH VASCULAR DILATORS
FDA 510(k)
FDA Class 2
·Cardiovascular
RADIFOCUS GLIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018
MEDIVATORS
FDA Adverse Event
Malfunction
·MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH·Product code FEB·December 14, 2010
COULTER® ACT DIFF 2¿ ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·January 22, 2013
OPTISENSE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 10, 2015
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·December 29, 2025
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DQX·May 16, 2024
RADIFOCUS GUIDEWIRE M
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 21, 2021
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·October 6, 2025
RADIFOCUS GUIDEWIRE M
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DQX·September 15, 2023
SMR CEMENTLESS FINNED STEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·December 15, 2021
GUIDE WIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 25, 2025
RADIFOCUS GUIDEWIRE
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DQX·December 5, 2023
RADIFOCUS GUIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·April 3, 2018
RADIFOCUS GUIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 23, 2026
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 11, 2026