7 results
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25ms
·
Sources: EU EUDAMED, US FDA
LKB 2189 ULTROPROCESSOR
FDA 510(k)
FDA Class 1
·Pathology
BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES)
FDA 510(k)
FDA Class 2
·Neurology
ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 19, 2012
ULTRACISION** HARMONIC SCALPEL** HAND PIECE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 2, 2014
CATHETER EXT SET-JAPAN ONLYMICOBORE 2 ADAPTER Y-JUNCTION
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·September 24, 2010
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