Company ยท US
Helix Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2013. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 17, 2013 | K130736 | BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS Helix Medical, LLC | LRC |
| Sep 17, 2013 | K131745 | BLOM-SINGER SEPTAL PERFORATION PROSTHESIS Helix Medical, LLC | LFB |
| Mar 3, 2010 | K093258 | BLOM-SINGER INDWELLING TEP OCCLUDER Helix Medical, LLC | EWL |
| Sep 4, 2008 | K082206 | BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES Helix Medical, LLC | EWL |
| Dec 26, 2002 | K023259 | INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 Helix Medical, Inc. | FDF |
| Jun 25, 1999 | K991587 | BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS Helix Medical, Inc. | EWL |
| Dec 9, 1994 | K945287 | INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE Helix Medical, Inc. | EWL |
| Dec 2, 1994 | K945288 | INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE Helix Medical, Inc. | EWL |
| Apr 15, 1994 | K932120 | BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES Helix Medical, Inc. | EWL |
| Dec 15, 1993 | K932163 | BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET Helix Medical, Inc. | EWL |
| May 17, 1993 | K930105 | BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. Helix Medical, Inc. | EWL |
| Sep 10, 1992 | K920090 | BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET Helix Medical, Inc. | EWL |
| Jun 30, 1992 | K915786 | BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. Helix Medical, Inc. | BYD |
| Feb 28, 1991 | K904729 | BLOM-SINGER SHOWER GUARD Helix Medical, Inc. | EWL |
| Aug 1, 1990 | K902112 | BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT Helix Medical, Inc. | EWL |
| Jun 14, 1990 | K900518 | BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT Helix Medical, Inc. | EWL |
| Mar 16, 1990 | K897005 | BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE Helix Medical, Inc. | JOH |
| Aug 24, 1989 | K894220 | HOUTS HYSTERECTOMY DRAIN Helix Medical, Inc. | GBW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2013 | Helix Medical LLC Blom-Singer Adjustable Tracheostoma Valve II
Models: BE8025H and BE8025H-R3 Terminated |
EWL | K821568 |
| Sep 7, 2012 | Helix Medical LLC 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 maintenan Terminated |
EWL | None listed |