| 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm (K242921) | Vitaltec Corporation | 2025-06-10 |
| Pilling Tracheostomy Tubes (K233713) | Teleflex Medical | 2024-03-22 |
| Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm (K192511) | Venner Medical (Singapore) Pte, Ltd. | 2020-07-22 |
| BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube (K173384) | Smiths Medical Ads, Inc. | 2018-04-10 |
| PRIMED TRACHEOSTOMY TUBES (MULTIPLE) (K120079) | Primed Halberstadt Medizintechnik GmbH | 2012-05-24 |
| WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (K101721) | Regulatory and Marketing Services, Inc. | 2011-03-24 |
| VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE (K100950) | Venner Medical (Singapore) Pte, Ltd. | 2010-07-13 |
| ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH (K100480) | Vitaltec Corporation | 2010-06-11 |
| VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC (K100283) | Cook, Inc. | 2010-04-23 |
| PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT (K083031) | Smiths Medical Asd, Inc. | 2009-08-18 |
| PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR (K073702) | Lazarus Medical, LLC | 2008-06-26 |
| TALKING TRACH (K062104) | Engineered Medical Systems, Inc. | 2007-04-20 |
| PORTEX PERCUTANEOUS TRACHEOSTOMY KIT (K060945) | Smiths Medical International | 2006-06-19 |
| TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 (K051587) | Tracoe Medical GmbH | 2005-10-25 |
| CS MEDICAL ADULT TTCF CATHETER (K050379) | Cs Medical, Inc. | 2005-07-12 |
| WELL LEAD TRACHEOSTOMY TUBE (K042684) | Well Lead Medical Instruments | 2005-02-17 |
| SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES (K031553) | Arcadia Medical Corporation | 2003-11-18 |
| BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE (K030570) | Portex , Ltd. | 2003-09-17 |
| PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA (K030381) | Portex , Ltd. | 2003-08-27 |
| RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED (K021764) | Rusch Intl. | 2002-07-23 |
| CRICOTHYROTOMY TUBE (K983000) | Polamedco, Inc. | 1999-10-27 |
| SCOOP 1 (K981080) | Transtracheal Systems | 1998-06-17 |
| TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). (K955461) | VBM Medizintechnik GmbH | 1997-03-19 |
| CPR TRACHEOTOMY CARE TRAY (K960205) | Custom Pack Reliability | 1996-08-27 |
| MOORE TRACHEOSTOMY TUBE (K962240) | Boston Medical Products, Inc. | 1996-08-15 |
| LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION) (K953559) | Seidel Medizin GmbH | 1996-05-16 |
| TRACHEOSTOMY CARE KIT (K952416) | Medi-Flex Hospital Products, Inc. | 1995-08-09 |
| SSV PHONATE(TM) SHILEY SPEAKING VALVE (K945406) | Mallinckrodt Medical Tpi, Inc. | 1995-02-27 |
| SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT (K945407) | Mallinckrodt Medical Tpi, Inc. | 1995-02-27 |
| TRACHEOSTOMY CARE KIT (K941470) | Clinical Resources, Inc. | 1995-02-14 |
| TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) (K924193) | American Healthcare Corp. | 1993-06-16 |
| TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL (K924191) | American Healthcare Corp. | 1993-04-02 |
| TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES (K924195) | American Healthcare Corp. | 1993-01-06 |
| TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686) (K924194) | American Healthcare Corp. | 1993-01-06 |
| TRACHEOSTOMY CARE SET WITH GLOVES (K923834) | American Healthcare Corp. | 1992-12-10 |
| CMI STOMA COVERS (K925249) | Community Medical Center | 1992-12-03 |
| LOW PROFILE TRACHEOSTOMY TUBE (K922749) | Concord/Portex | 1992-09-02 |
| TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE (K920281) | Trinity Laboratories, Inc. | 1992-08-27 |
| TRACHEOSTOMY CARE KIT (K921281) | Trinity Laboratories, Inc. | 1992-08-27 |
| BIVONA TRACHEAL T-TUBE STENT (K920604) | Bivona Medical Technologies | 1992-07-27 |
| EMERGENCY PERCUTANEOUS CRICOTHYROIDOTOMY KIT,MODIF (K914743) | Pertrach | 1992-07-10 |
| TRACHEOSTOMY TUBE AND CUFF (K912124) | Concord/Portex | 1991-08-16 |
| BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE (K912469) | Bivona Medical Technologies | 1991-06-19 |
| D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES (K903730) | Concord/Portex | 1990-09-25 |
| PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE (K901920) | Primecare, Inc. | 1990-08-17 |
| MODIFIED SCOOP TRANSTRACHEAL CATHETERS (K902281) | Transtracheal Systems | 1990-08-10 |
| SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER (K901079) | L H M Ent., Inc. | 1990-05-18 |
| SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE (K901078) | L H M Ent., Inc. | 1990-05-18 |
| SHILEY PHONATION VALVE (K900548) | Shiley, Inc. | 1990-04-23 |
| STAT-TRACH(TM) VENTILATION CATHETER (K894096) | Statron Corp. | 1990-03-16 |
| TRACHEOSTOMY TRAY (K896798) | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-22 |
| TRAUMAFUSE TRACH SHIELD (K895162) | The Traumafuse Co. | 1990-01-09 |
| HEIMLICH MICRO TRACH (K895130) | Ballard Medical Products | 1989-11-07 |
| HOOD PEDIATRIC TRACHEOSTOMY TUBE (K893866) | Hood Laboratories | 1989-08-07 |
| MODIFIED ADULT CRICOTHYROIDOTOMY KIT (K885139) | Pertrach | 1989-05-25 |
| AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES) (K890342) | Eastmed Enterprises, Inc. | 1989-04-27 |
| SHILEY PERC TRACHEOSTOMY SYSTEM (K884730) | Shiley, Inc. | 1989-01-17 |
| PREMIER DECANNULATION STOPPER (K884015) | Premier Dental | 1988-11-03 |
| FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT. (K884427) | Bivona Medical Technologies | 1988-11-02 |
| HOOD TRACHEAL STOMA BUTTON (K882430) | Hood Laboratories | 1988-06-28 |
| SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE (K880614) | Shiley, Inc. | 1988-03-09 |
| SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT (K874450) | Surgitech C/O Collier, Shannon, Rill & Scott | 1988-02-29 |
| PREFILLED WATER FOR IRRIGATION USP (K880316) | Automatic Liquid Packaging, Inc. | 1988-02-29 |
| PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP (K880317) | Automatic Liquid Packaging, Inc. | 1988-02-29 |
| MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES (K880247) | Shiley, Inc. | 1988-02-12 |
| QUICKTRACH (K874742) | Posey Co. | 1987-12-31 |
| TODD MEDICAL/SKILLED CARE PRODUCTS (K873499) | Todd Medical, Inc. | 1987-11-24 |
| LARKEL DEVICE W/ATTACHMENTS A-H (K872486) | Seidel Medizin GmbH | 1987-09-16 |
| MODIFIED PERTRACH DISP. PEDIATRIC PERCUT. TRACHEO. (K871199) | Frederic J. Toye, M.D. | 1987-06-08 |
| JOHNSON INTRATRACHEAL OXYGEN CATHETER SET (K870181) | Cook, Inc. | 1987-05-14 |
| SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE (K865061) | Shiley, Inc. | 1987-01-15 |
| TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN) (K862436) | Acutronic Medical Systems AG | 1986-11-03 |
| RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM (K862909) | Intl. Medical Devices , Ltd. | 1986-09-09 |
| MINI-TRACH KIT (K862167) | Portex, Inc. | 1986-08-06 |
| FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES (K862267) | Bivona Medical Technologies | 1986-06-18 |
| MICRO-TRACHEOSTOMY CARE KIT (K861645) | Aci Medical, Inc. | 1986-05-09 |
| TRACHEAL TUBES (K853051) | Erie Medical | 1986-04-11 |
| TRACHEOSTOMY CARE KIT (K855130) | Dynarex Corp. | 1986-03-04 |
| TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER (K854252) | Transtracheal Systems | 1986-02-03 |
| LARYNGECTOMY TUBE, CUFFED (K860176) | Sheridan Catheter Corp. | 1986-01-27 |
| THE HOOD LIFE SAVER (K853511) | Hood Laboratories | 1985-12-19 |
| CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE (K853419) | Hood Laboratories | 1985-12-06 |
| LGT TUBE (K852413) | Mallinckrodt Critical Care | 1985-09-05 |
| BIVONA TRACHEOSTOMA VALVE II (K852272) | Bivona Medical Technologies | 1985-07-08 |
| PASSY-MUIR TRACH VALVE (K851016) | Passy & Passy, Inc. | 1985-06-07 |
| BFW VOICE GENERATOR (K851462) | Bfw Laboratories, Inc. | 1985-05-28 |
| TRACHEOSTOMY CARE KIT (K850446) | Paco Research Corp. | 1985-03-11 |
| TRACHEOSTOMY CARE TRAY (K850445) | Paco Research Corp. | 1985-03-11 |
| TRACHEOSTOMY CARE KIT (K850456) | Excel Health Care Products | 1985-03-11 |
| WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR (K843785) | Intl. Medical Devices , Ltd. | 1984-10-23 |
| SHILEY DISPOS. CANNULA FENESTRATED LOW (K843729) | Shiley, Inc. | 1984-10-19 |
| SHILEY DISPOS. DECANNULATION PLUG W/SW/ (K843730) | Shiley, Inc. | 1984-10-19 |
| PERCUTANEOUS CRICOTHYROIDOTOMY (K822440) | Frederic J. Toye, M.D. | 1984-10-15 |
| TRACHEAL TUBE 16 GAUGE-1.65MM- (K832466) | Erie Medical | 1984-09-19 |
| ALL-HANDS TRACHEOSTOMY CARE SET 0101 (K842415) | All-Hands Medical Supply, Inc. | 1984-07-06 |
| MONTGOMERY TRACHEAL T-TUBE (K841266) | E. Benson Hood Laboratories, Inc. | 1984-06-14 |
| PEDIA-TRAKE CRICOTHYROTOMY KIT (K840925) | Intl. Medical Devices , Ltd. | 1984-05-02 |
| COMMUNI-TRACH TUBE (K841546) | Implant Technology, Inc. | 1984-04-30 |
| 3-DAY BIOINDICATOR RELEASE FOR RESPIR (K833832) | Shiley, Inc. | 1984-03-15 |
| DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY (K840539) | Shiley, Inc. | 1984-03-09 |