10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FlareHawk Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
ELMED
FDA UDI
ELMED INCORPORATED·00842180186361·Irrigation/injection needles. Olive tip. Overal...
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981042059·31x24mm Trial Rasp 16mm 12 deg
SensorX
FDA 510(k)
FDA Class 2
·Dental
ICSI-100
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BONESCALPEL® 20MM, UNILATERAL SERRATIONS DISPOSABLE
FDA Adverse Event
Injury
·MISONIX, INC.·Product code LFL·April 30, 2026
MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 21, 2008
RIATA ACTIVE FIXATION
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
54 CM UNIPOLAR LEAD
FDA Adverse Event
Malfunction
·GREATBATCH MEDICAL·Product code DTB·July 18, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025