7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGICAL GARMENTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SILASTIC BRAND PENILE IMPLANT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
FDA 510(k)
FDA Class 2
·Anesthesiology
PUMP IN STYLE ADVANCED BREASTPUMP SHOULDER BAG
FDA Adverse Event
Other
·MEDELA, INC·Product code HGX·October 13, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 30, 2014
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·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