9 results
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17ms
·
Sources: EU EUDAMED, US FDA
LANCER GLYCOSYLATED HEMOGLOBIN ASSAY
FDA 510(k)
FDA Class 2
·Hematology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517366856·CoRoent® Sm, 10x11x14mm 5° Lordotic
Probe Covers for Thermometers
FDA 510(k)
FDA Class 2
·General Hospital
EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·June 24, 2025
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·March 21, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
PULSE GEN MODEL
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·February 29, 2008
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