7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MOSAIC ECO2 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TruClear Elite Hysteroscope
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PERCUNAV MP008R-B BUTTON PROBE
FDA Adverse Event
Other
·PHILIPS HEALTHCARE·Product code JAK·October 13, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 30, 2014
PENUMBRA MICROCATHETER 025 (PX400 MICROCATHETER)
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code DQY·December 19, 2012
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025