7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUPPLEMENTAL FEEDING SYSTEM
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
PROPPER SERACULT
FDA 510(k)
FDA Class 2
·Hematology
COLTENE ORALLOY MAGICAPS
FDA 510(k)
FDA Class 2
·Dental
PROGRASP FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 2, 2014
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·November 8, 2012
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 15, 2015
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