7 results
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18ms
·
Sources: EU EUDAMED, US FDA
HSV ANTIGEN ELISA KIT
FDA 510(k)
FDA Class 2
·Microbiology
HAND CONTROLLED PENCIL OR SWITCH HAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LARYNGOTELESCOPE CURVED MLC-1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
UNKNOWN HIP IMPLANT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 28, 2014
PULSE GEN MODEL 106
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·November 15, 2012
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·September 10, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024