Enhancement Medical expression

  • Model / Serial
    Lot numbers to follow: Z36-074, Q36-136, Q36-137, Q36-138, Q36-139, Q36-140, R36-168, R36-169, R36-170, R36-171, R36-172, S36-189, S36-190, S36-191, S36-192, S36-194, S36-202, S36-203.  RECALL EXPANDED 7-8-2014 to include ALL LOTS.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Enhancement Medical, LLC, 10201 Innovation Drive, Suite 450, Wauwatosa WI 53226
  • Source
    USFDA