8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Mobility+ Enteral Feeding System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRIAL HEAD FOR BROACH ESOP HA D.32 0
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489226786·
MEDCOMP SC4
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OMNI Surgical System
FDA 510(k)
FDA Class 2
·General Hospital
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014
EXTERNAL CATHETER SEGMENT FOR HICKMAN 7 FR PED
FDA Adverse Event
C. R. BARD INC. (BASD)·Product code LJS·July 25, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018