9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Open Rib
FDA 510(k)
FDA Class 2
·Radiology
ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
FDA 510(k)
FDA Class 2
·Immunology
SYNERGEYES HYBRID CONTACT LENS
FDA Adverse Event
Injury
·SYNERGEYES·Product code HQD·October 27, 2014
UNKNOWN MIS BUR PRODUCT
FDA Adverse Event
Malfunction
·STRYKER IRELAND LTD.·Product code HBE·August 16, 2011
ASR UNI FEMORAL IMPL SIZE 53
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 12, 2013
ALIYA
FDA Adverse Event
Injury
·NEAUVIA NORTH AMERICA, INC·Product code GEX·May 5, 2026
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024