27 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257073414·PROTECT PATELLA TRACKING BRACE, LT, MD
Health Support
FDA UDI
Carolon Company·00078301115020·
Health Support
FDA UDI
Carolon Company·00078301111527·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321115120·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311115120·
Arthrex®
FDA UDI
ARTHREX, INC.·00888867288072·Dynanite NiTi Staple w/Instrs 11Wx15\12L
Arthrex®
FDA UDI
ARTHREX, INC.·00888867287945·Nitinol Compression Staple, 11W x 15\12L
MMODIFICATION TO LAMINARIA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4).
FDA 510(k)
FDA Class 2
·Cardiovascular
12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·June 23, 2025
12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·April 3, 2024
12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·February 12, 2025
12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·June 26, 2025
12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·November 17, 2023
SURETEK
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·November 16, 2023
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
UNKNOWN DEPUY 1 CEMENT
FDA Adverse Event
Injury
·DEPUY CMW·Product code LOD·May 13, 2011
12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·August 20, 2024