Panels › Anesthesiology › Product code BTR · Class 2
Tube, Tracheal (W/Wo Connector)
Regulation 868.5730
2510(k)s in 12 months (242 all time)
1recalls in 12 months (227 all time)
203recalls that name a 510(k)
Top companies in BTR
| Company | 510(k)s | Recalls |
|---|---|---|
| Teleflex Incorporated | 1 | 127 |
| Teleflex Medical | 2 | 48 |
| Smiths Medical | 0 | 17 |
| Smiths Medical Asd, Inc. | 2 | 10 |
| Sheridan Catheter Corp. | 11 | 0 |
| Mallinckrodt Critical Care | 10 | 0 |
| Rusch, Inc. | 10 | 0 |
| Bivona Medical Technologies | 8 | 0 |
| Covidien | 6 | 1 |
| Polamedco, Inc. | 7 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2009 | Smiths Medical Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.0 mm
Product Code: 100/134/030.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 3.5 mm
Product Code: 100/127/035.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 3.0 mm
Product Code: 100/127/030.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 2.5 mm
Product Code: 100/127/025.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 3.5 mm
Product Code: 100/141/035.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 3.0 mm
Product Code: 100/141/030.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 2.5 mm
Product Code: 100/141/025.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Tracheal Tube, Cut to Length, Oral, Siliconized, 3.5 mm
Product Code: 100/126/035.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Tracheal Tube, Cut to Length, Oral, Siliconized, 3.0 mm
Product Code: 100/126/030.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Tracheal Tube, Cut to Length, Oral, Siliconized, 2.5 mm
Product Code: 100/126/025.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Tracheal Tube, Oral/Nasal, Siliconized, 3.5 mm
Product Code: 100/111/035.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Tracheal Tube, Oral/Nasal, Siliconized, 3.0 mm
Product Code: 100/111/030.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Tracheal Tube, Oral/Nasal, Siliconized, 2.5 mm
Product Code: 100/111/025.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Uncuffed Paediatric Sized Tracheal Tube
Oral Nasal, Ivory 3.5 mm,
Product Code: 100/105/035.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Uncuffed Paediatric Sized Tracheal Tube
Oral Nasal, Ivory 3.0 mm,
Product Code: 100/105/030.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Uncuffed Paediatric Sized Tracheal Tube, Oral Nasal , Ivory 2.5 mm,
Product Code: 100/105/025.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| Aug 26, 2009 | Teleflex Medical Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314, Teleflex Medical Ltd, Research Triangle Park, NC 27709
Used for oral or nasal intubation for airway management. Terminated |
BTR | K822082 |
| Aug 26, 2009 | Teleflex Medical Sheridan Preformed Cuffed Tracheal Tube, Nasal 6.5, Catalog Number: 5-22313, Teleflex Medical Ltd, Research Triangle Park, NC 27709
Used for oral or nasal intubation for airway management. Terminated |
BTR | K822082 |
| Aug 8, 2007 | Kimberly-Clark Corporation Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0mm and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgium, Made Terminated |
BTR | K050803 |
| Aug 8, 2007 | Kimberly-Clark Corporation Kimberly-Clark Microcuff Endotracheal Tube, Pediatric Oral/Nasal Magill, sizes 3.0mm, 3.5mm, 4.0mm, and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgiu Terminated |
BTR | K050803 |
| Nov 2, 2006 | Teleflex Medical Sheridan Preformed Cuffed Nasal Tracheal Tube, 7.5 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-22 Terminated |
BTR | K822082 |
| Nov 2, 2006 | Teleflex Medical Sheridan Preformed Cuffed Oral Tracheal Tube, 5.0 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-222 Terminated |
BTR | K822082 |
| Nov 2, 2006 | Teleflex Medical Sheridan Preformed Uncuffed Oral Tracheal Tube, 3.0 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-2 Terminated |
BTR | K822082 |
| Jul 25, 2006 | Microcuff Gmbh Microcuff Adult Endotracheal Tubes - Oral/Nasal Magill with Murphy Eye *
ID Size: 5,0mm, Microcuff Product Reference: I-HMICU-50;
ID Size: 5.5mm, Product Reference: I-HMICU- 55;
ID Size: 6.0mm, Prod Terminated |
BTR | None listed |
| Jul 25, 2006 | Microcuff Gmbh Microcuff Pediatric Endotracheal Tubes - Oral Pre-Curved:
ID Size: 3,0mm, Microcuff Product Reference: I-MPEDC-30;
ID Size: 3,5mm, Product Reference: I-MPEOC-35;
ID Size: 4,0mm, Product Reference: Terminated |
BTR | None listed |
| Jul 25, 2006 | Microcuff Gmbh Microcuff Endotracheal Tube; Pediatric Oral/Nasal Magill:
ID Size: 3,0mm, Microcuff Product Reference: I-MPEDC-30;
ID Size: 3,5mm, Product Reference: I-MPEDC-35;
ID Size: 4,0mm, Product Reference: Terminated |
BTR | K050803 |
| Mar 10, 2005 | Teleflex Medical Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patient's trachea via the mouth to maintain an open airway; Hudson RCI, Temecula, CA Terminated |
BTR | K822082 |
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