10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Atellica CH Magnesium (Mg)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ECHO(TM) HIP SYSTEM INSTRUMENTATION
FDA UDI
Biomet Orthopedics, LLC·00880304463530·
Echo® Hip System Instrumentation
FDA UDI
Biomet Orthopedics, LLC·00887868474491·
K162309
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code PGW·November 14, 2019
CONSENSUS TAPERSET HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REVEAL XT
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·October 10, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
OCTRODE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 6, 2013
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026