8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KIMBERLY-CLARK PROTECTIVE SLEEVE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515225947·Periosteal Elevator, #853, Double ended
Meron Plus QM
FDA 510(k)
FDA Class 2
·Dental
COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE
FDA 510(k)
FDA Class 2
·Neurology
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·October 15, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 30, 2014
HERO GRAFT
FDA Adverse Event
Injury
·HEMOSPHERE, INC.·Product code DSY·December 19, 2012
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025