FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K031553 |
ARCADIA MEDICAL CORPORATION |
SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES |
11/18/2003 |
K962240 |
BOSTON MEDICAL PRODUCTS, INC. |
MOORE TRACHEOSTOMY TUBE |
08/15/1996 |
K100283 |
COOK, INC. |
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC |
04/23/2010 |
K050379 |
CS MEDICAL INC. |
CS MEDICAL ADULT TTCF CATHETER |
07/12/2005 |
K960205 |
CUSTOM PACK RELIABILITY |
CPR TRACHEOTOMY CARE TRAY |
08/27/1996 |
K062104 |
ENGINEERED MEDICAL SYSTEMS, INC. |
TALKING TRACH |
04/20/2007 |
K073702 |
LAZARUS MEDICAL LLC |
PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR |
06/26/2008 |
K983000 |
POLAMEDCO, INC. |
CRICOTHYROTOMY TUBE |
10/27/1999 |
K030570 |
PORTEX LTD. |
BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE |
09/17/2003 |
K030381 |
PORTEX LTD. |
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA |
08/27/2003 |
K120079 |
PRIMED HALBERSTADT MEDIZINTECHNIK GMBH |
PRIMED TRACHEOSTOMY TUBES (MULTIPLE) |
05/24/2012 |
K101721 |
REGULATORY AND MARKETING SERVICES, INC. |
WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA |
03/24/2011 |
K021764 |
RUSCH INTL. |
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED |
07/23/2002 |
K953559 |
SEIDEL MEDIZIN GMBH |
LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION) |
05/16/1996 |
K173384 |
Smiths Medical ADS, Inc. |
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube |
04/10/2018 |
K083031 |
SMITHS MEDICAL ASD, INC. |
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT |
08/18/2009 |
K060945 |
SMITHS MEDICAL INTERNATIONAL |
PORTEX PERCUTANEOUS TRACHEOSTOMY KIT |
06/19/2006 |
K051587 |
TRACOE MEDICAL GMBH |
TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 |
10/25/2005 |
K981080 |
TRANSTRACHEAL SYSTEMS |
SCOOP 1 |
06/17/1998 |
K955461 |
VBM MEDIZINTECHNIK GMBH |
TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). |
03/19/1997 |
K100950 |
VENNER MEDICAL (SINGAPORE) PTE LTD |
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE |
07/13/2010 |
K192511 |
Venner Medical (Singapore) PTE Ltd |
Venner PneuXÖ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuXÖ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuXÖ TT (Tracheostomy Tube) Size 9.0 mm |
07/22/2020 |
K100480 |
VITALTEC CORPORATION |
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH |
06/11/2010 |
K042684 |
WELL LEAD MEDICAL INSTRUMENTS |
WELL LEAD TRACHEOSTOMY TUBE |
02/17/2005 |