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Helix Medical, Inc.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K023259 INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200FDF2002-12-26 View
510(k) K991587 BLOM-SINGER INDWELLING 2000 VOICE PROSTHESISEWL1999-06-25 View
510(k) K945287 INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICEEWL1994-12-09 View
510(k) K945288 INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICEEWL1994-12-02 View
510(k) K932120 BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHESEWL1994-04-15 View
510(k) K932163 BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPETEWL1993-12-15 View
510(k) K930105 BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.EWL1993-05-17 View
510(k) K920090 BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SETEWL1992-09-10 View
510(k) K915786 BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID.BYD1992-06-30 View
510(k) K904729 BLOM-SINGER SHOWER GUARDEWL1991-02-28 View
510(k) K902112 BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENTEWL1990-08-01 View
510(k) K900518 BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KITEWL1990-06-14 View
510(k) K897005 BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBEJOH1990-03-16 View
510(k) K894220 HOUTS HYSTERECTOMY DRAINGBW1989-08-24 View
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