11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UST-974-5 CONVEX TRANSDUCER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756982771·HAND PACK
UCR
FDA UDI
Seaspine Orthopedics Corporation·10889981079826·UCR FIXED TIP INSERTER SLEEVE
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756104487·WRIST AND FOREARM
RadiForce MX216
FDA 510(k)
FDA Class 2
·Radiology
SFC VERTEBRAL BODY REPLACEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTO·July 11, 2017
CHEMO AID ADD-A-LINE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·November 30, 2010
ACUITY
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·January 11, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 2, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024