20 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Visera Elite II Video System Center, Visera Elite II Endoeye 3D
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694009867·3.0mm x 26mm Cannulated Lag Screw
SAIPH
FDA UDI
MATORTHO LTD·05055455506084·SAIPH Femur Cemented Yellow Right Size 2
OsteoMed
FDA UDI
OSTEOMED LLC·00845694071208·Cannulated 3.0 x 26mm Lag Screw Sterile Qty 5
FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
ELECTRO SENSOR -BODY COMPOSITION
FDA 510(k)
FDA Class 2
·Cardiovascular
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 22, 2014
VASOVIEW HEMOPRO 2 EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·July 21, 2011
RENAISSANCE 26 OBS 10/25/04
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 27, 2013
ELITE IQ
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·July 4, 2024
ELITE IQ
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 6, 2024
ELITE IQ
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 25, 2025
ELITE IQ
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·September 21, 2021
ELITE IQ
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·April 21, 2026
ELITE IQ
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·December 17, 2021
ELITE IQ
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·April 13, 2022
ELITE IQ
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·September 16, 2025
ELITE IQ
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·July 20, 2022
ELITE IQ
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 4, 2022
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020