6 results
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24ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Tapping Variable Screw Caddy (176-513). Medtronic Sofamor Danek USA, Inc. This instrument is a precision device which incorporates a measuring function.
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code XLH·July 6, 2011
ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy (976-516). Medtronic Sofamor Danek USA, Inc. This instrument is a precision device which incorporates a measuring function.
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code XLH·July 6, 2011
PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA. PS-MTM is also intended for the stabilization, transportation, and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis (MTB) DNA from human samples.
FDA Recall
Open, Classified
·LONGHORN VACCINES AND DIAGNOSTIC 2 Bethesda Metro Cente·Product code QBD·June 3, 2020
Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C
FDA Recall
Open, Classified
·Product code OGR·February 25, 2026
Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)
FDA Recall
Open, Classified
·North Coast Medical Inc·Product code ILH·August 18, 2023
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JLH·May 10, 2021