8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DCI ENDOSCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984369·anteriors; shade B4; mould R 60
APDYNE PHENOL APPLICATOR KIT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM
FDA 510(k)
FDA Class 2
·Radiology
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013
FREESTYLE LITE
FDA Adverse Event
Injury
·Product code NBW·February 10, 2011
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·August 6, 2014
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024