7 results
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25ms
·
Sources: EU EUDAMED, US FDA
INSTANT EOSIN-ALCOHOLIC
FDA 510(k)
FDA Class 1
·Hematology
Full Automatic(NIBP) Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE
FDA 510(k)
FDA Class 1
·Dental
NELLCOR OXIMAX N-65
FDA Adverse Event
Malfunction
·SANMINA-SCI SYSTEMS·Product code DQA·April 8, 2014
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 22, 2010
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KWA·December 19, 2012
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025