9 results
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18ms
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Sources: EU EUDAMED, US FDA
NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515246829·Negus Tonsil Artery Fcps, wide, 7 1/2"
BioZorb LP Marker
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA
FDA 510(k)
FDA Class 2
·Dental
SEE H10
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 17, 2020
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 9, 2013
BIVONA TTS TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code JOH·January 3, 2011
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·July 17, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024