9 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACUMED MODULAR SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Armada
FDA UDI
Nuvasive, Inc.·00887517235602·Armada Ti 3CO Rectractor, 25mm Spoon
Bioseal Inc.
FDA UDI
BIOSEAL·00630094199252·Silicone Mouth Prop
IREX CARDIOPLAN
FDA 510(k)
FDA Class 2
·Cardiovascular
087 Balloon Guide Catheter System
FDA 510(k)
FDA Class 2
·Cardiovascular
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 4, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 15, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·August 8, 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