Myoscience, Inc.
Myoscience, Inc. holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2018, with 2 FDA device recalls on record.
Top product codes for Myoscience, Inc.
FDA recalls by Myoscience, Inc.
- Z-2201-2015 — iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device The myoscience iovera device is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The iovera device is not indicated for treatment of central nervous system tissue
- Z-1781-2013 — Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV (a.k.a. iovera) is not indicated for treatment of central nervous system tissue.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Myoscience, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.