Helix Medical LLC

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0128-2014Class IIIBlom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3October 1, 2013
Z-2336-2012Class IIIBLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesoMarch 8, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K130736BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESISDecember 17, 2013
K131745BLOM-SINGER SEPTAL PERFORATION PROSTHESISSeptember 17, 2013
K093258BLOM-SINGER INDWELLING TEP OCCLUDERMarch 3, 2010
K082206BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIESSeptember 4, 2008
K023259INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200December 26, 2002
K991587BLOM-SINGER INDWELLING 2000 VOICE PROSTHESISJune 25, 1999
K945287INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICEDecember 9, 1994
K945288INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICEDecember 2, 1994
K932120BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHESApril 15, 1994
K932163BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPETDecember 15, 1993
K930105BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.May 17, 1993
K920090BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SETSeptember 10, 1992
K915786BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID.June 30, 1992
K904729BLOM-SINGER SHOWER GUARDFebruary 28, 1991
K902112BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENTAugust 1, 1990
K900518BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KITJune 14, 1990
K897005BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBEMarch 16, 1990
K894220HOUTS HYSTERECTOMY DRAINAugust 24, 1989