49 results
·
52ms
·
Sources: EU EUDAMED, US FDA
EXPRESSIONS
FDA Adverse Event
Injury
·ENHANCEMENT MEDICAL LLC·Product code LYA·October 14, 2014
Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is currently being used off-label as a subcutaneously injected dermal filler.
FDA Recall
Terminated
·Enhancement Medical, LLC·Product code LMH·August 7, 2013
Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is currently being used off-label as a subcutaneously injected dermal filler.
FDA Enforcement
Class I
·Terminated·Enhancement Medical, LLC·August 20, 2014
NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·October 18, 2024
FREESTYLE HANDS-FREE BREASTPUMP
FDA Adverse Event
Injury
·MEDELA AG·Product code HGX·November 29, 2017
NEXUS® BONESCALPEL® 20MM, UNI-LATERAL SERRATED BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·November 6, 2024
NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·October 31, 2024
NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·November 24, 2024
NEXUS® BONESCALPEL® MIS 10 MM BLADE AND SHEATH + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·November 6, 2024
BONESCALPEL® BONESHAVER, MICROHOOK DISPOSABLE
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·November 24, 2024
NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·October 31, 2024
NEXUS® BONESCALPEL® 10MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·May 1, 2025
NEXUS® BONESCALPEL® 10MM, BLUNT BLADE + IRRIGATION TUBING
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·March 14, 2025
FREESTYLE HANDS-FREE BREASTPUMP
FDA Adverse Event
Injury
·MEDELA AG·Product code HGX·November 16, 2017
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·ACUMED, LLC·Product code HWC·May 2, 2024
NEXUS® BONESCALPEL® 25MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·November 13, 2024
NEXUS® SONASTAR® NOTCHED ASPIRATION TIP 1.9MM STANDARD SHORT, + IRRIGATION & ASP
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·October 9, 2024
NEXUS® BONESCALPEL® 25MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·November 13, 2024
NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·November 21, 2024
NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·November 21, 2024