10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Smartpump 3.0 Double Electric Breast Pump
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694021135·FPS 2.7mm x 26mm Locking Screw
OsteoMed
FDA UDI
OSTEOMED LLC·00845694075404·FPS 2.7 x 26mm Locking Screw Sterile Qty 5
STAYFUSE GT-IP
FDA 510(k)
FDA Class 2
·Orthopedic
CPI RAD VISION
FDA 510(k)
FDA Class 2
·Radiology
BD INSYTE AUTOG BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 14, 2024
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014
STERLING¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·August 25, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·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