10 results
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20ms
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Sources: EU EUDAMED, US FDA
LOUNGE, TILT-A-BODY STRETCH
FDA 510(k)
FDA Class 1
·Physical Medicine
Erchonia FX-635
FDA 510(k)
FDA Class 2
·Physical Medicine
SERALUTE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CARELINK
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code KRG·October 15, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·December 31, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Other
·STRYKER CORP, MEDICAL DIV·Product code FNL·August 2, 2010
UNSPECIFIED BD ALARIS INFUSION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·May 28, 2021
BD ALARIS¿ SECONDARY SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 24, 2023
UNSPECIFIED BD ALARIS¿ INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 29, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024