Helix Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 18
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Helix Medical, Inc. makes
Helix Medical, Inc. manufactures accessories and devices for tracheoesophageal fistula management, including voice prostheses, indwelling plug and valved insert systems, and associated accessories like shower guards and humidification filters. The portfolio also includes tracheoesophageal puncture kits, stents, and silicone laryngectomy tubes. Additional products support surgical drainage, such as the Houts hysterectomy drain, and protective accessories for endoscopic procedures, like the soft sleeve splint for colonoscopes.
The company’s devices are classified under FDA regulations as Class I and Class II, with most submissions recorded via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, reflecting their authorised status under US medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 18 devicesFDA recalls
FDA recall records list 2 recalls initiated by Helix Medical, Inc., the earliest on 2012-03-08 and the most recent on 2013-10-01. By recorded status: 2 terminated. The reasons filed fall into these groups: packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 1 Oct 2013 Z-0128-2014 Class III Terminated InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATSV II Valve product cannot be used as intended without the product body.
2012
- 8 Mar 2012 Z-2336-2012 Class III Terminated Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Frequently asked questions
How many devices does Helix Medical, Inc. have in the registry?
The registry currently lists 18 devices for Helix Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Helix Medical, Inc.'s devices?
Among its 18 most recently registered devices, Helix Medical, Inc. has devices listed in FDA 510(k) (18 devices).
What risk classes do Helix Medical, Inc.'s devices fall under?
Among its 18 most recently registered devices, the classes recorded for Helix Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Helix Medical, Inc.?
FDA recall records list 2 recalls initiated by Helix Medical, Inc., the most recent initiated on 1 Oct 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Helix Medical, Inc. in the registry?
The most recently registered devices listed for Helix Medical, Inc. include BLOM-SINGER SEPTAL PERFORATION PROSTHESIS, INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE, BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS and BLOM-SINGER SHOWER GUARD.