9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Origin Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
EarQ
FDA UDI
Oticon A/S·05707131343147·G20, MINIRITE 312 2.4G C091 EARQ
LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ZENOSTAR MAGIC GLAZE
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 23, 2025
GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA
FDA Adverse Event
Malfunction
·OBTECH MEDICAL SARL·Product code LTI·October 8, 2008
2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PLATE 6H HD/4H SHAFT/LEFT
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·June 27, 2013
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 21, 2011
DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·July 10, 2019