8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STAGO FACTOR XII-DEFICIENT PLASMA
FDA 510(k)
FDA Class 2
·Hematology
SeaSpine Spacer System - Ventura™
FDA UDI
Seaspine Orthopedics Corporation·10889981033620·Ventura Trial, 11mm x 28mm x 15mm
SleepStageML
FDA 510(k)
FDA Class 2
·Neurology
BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000
FDA 510(k)
FDA Class 2
·Physical Medicine
BLAKE DRAIN
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code KOG·January 29, 2013
ENDO STITCH 10MM SUTURING DEVICE
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL·Product code KOG·December 3, 2010
SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·July 14, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024