Company ยท GB
Smiths Medical
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2019. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
27recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 24, 2019 | K181660 | Acapella Choice Blue Vibratory PEP Device Smiths Medical | BWF |
| May 26, 2005 | K050166 | PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT Smiths Medical, GB | BWC |
| Jul 13, 2004 | K041348 | PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA Smiths Medical, GB | JOH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2011 | Smiths Medical Value Pack General Anesthesia Kit, (containing Reorder Number: 001421 Oxygen Face Mask)
Reorder Number: VP1302
For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patient Terminated |
BYF | None listed |
| Jun 24, 2011 | Smiths Medical First Breath Adult Venturi Oxygen Mask with Corrugated Tubing, O2 Diluter Jets (6), Oxygen Tubing, and Nebulizer Hood. (Non-latex) 50/CA
Reorder Number: 002610
For acute use, e.g. Post-op recovery, m Terminated |
BYF | None listed |
| Jun 24, 2011 | Smiths Medical First Breath Adult Face Tent with Tubing 188cm (5ft.) (Non-latex)
Reorder Number: 001492
Face Tent Is a special type of aerosol mask used when the delivery of oxygen is not the primary objective. Nor Terminated |
BYG | None listed |
| Jun 24, 2011 | Smiths Medical First Breath Adult Face Tent (Non-latex) 50/CA
Reorder Number: 001490
Face Tent Is a special type of aerosol mask used when the delivery of oxygen is not the primary objective. Normally this type of Terminated |
BYG | None listed |
| Jun 24, 2011 | Smiths Medical First Breath Pediatric Aerosol Mask (Non-Latex) 50/CA
Reorder Number: 001476
For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is de Terminated |
BYG | None listed |
| Jun 24, 2011 | Smiths Medical First Breath PEDIATRIC Medium Concentration Oxygen Mask with Tubing, 213cm (7ft) (Non-latex) 50/CA
Reorder Number: 001471
Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, pat Terminated |
BYG | None listed |
| Jun 24, 2011 | Smiths Medical First Breath ADULT Elongated Non-Rebreather Oxygen Mask with 1L Reservoir Bag & Tubing, 213cm (7ft.) 50/CA
Reorder Number: 001431
Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal tr Terminated |
BYG | None listed |
| Jun 24, 2011 | Smiths Medical First Breath Adult Aerosol Mask (Non-latex) 50/CA
Reorder Number: 001426
Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more Terminated |
BYG | None listed |
| Jun 24, 2011 | Smiths Medical First Breath 3 in 1 Oxygen Mask with Reservoir Bag (1L) and Tubing, 213cm (7ft) (Non-latex) 50/CA
Re-Order Number: 001423
Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, pa Terminated |
BYG | None listed |
| Jun 24, 2011 | Smiths Medical First Breath Adult Oxygen Mask with Tubing, 213cm (7ft)
Reorder Number: 001421
Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring Terminated |
BYG | None listed |
| Sep 18, 2009 | Smiths Medical Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.5 mm
Product Code: 100/134/035.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
| 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 |