Helix Medical LLC
FDA Regulatory Profile
Helix Medical LLC appears in FDA public data with 2 recalls, 18 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0128-2014, Class III) was initiated on October 1, 2013. Its most recent 510(k) clearance was granted on December 17, 2013.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 18
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0128-2014 | Class III | Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3 | October 1, 2013 |
| Z-2336-2012 | Class III | BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoeso | March 8, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K130736 | BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS | December 17, 2013 |
| K131745 | BLOM-SINGER SEPTAL PERFORATION PROSTHESIS | September 17, 2013 |
| K093258 | BLOM-SINGER INDWELLING TEP OCCLUDER | March 3, 2010 |
| K082206 | BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES | September 4, 2008 |
| K023259 | INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 | December 26, 2002 |
| K991587 | BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS | June 25, 1999 |
| K945287 | INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE | December 9, 1994 |
| K945288 | INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE | December 2, 1994 |
| K932120 | BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES | April 15, 1994 |
| K932163 | BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET | December 15, 1993 |
| K930105 | BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. | May 17, 1993 |
| K920090 | BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET | September 10, 1992 |
| K915786 | BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. | June 30, 1992 |
| K904729 | BLOM-SINGER SHOWER GUARD | February 28, 1991 |
| K902112 | BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT | August 1, 1990 |
| K900518 | BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT | June 14, 1990 |
| K897005 | BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE | March 16, 1990 |
| K894220 | HOUTS HYSTERECTOMY DRAIN | August 24, 1989 |