Helix Medical, LLC
Helix Medical, LLC holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2013, with 2 FDA device recalls on record.
Top product codes for Helix Medical, LLC
FDA recalls by Helix Medical, LLC
- Z-0128-2014 — Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
- Z-2336-2012 — BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.
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 Helix Medical, LLC
Data sourced from openFDA. This site is unofficial and independent of the FDA.