Panels › Anesthesiology › Product code BSR · Class 1
Stylet, Tracheal Tube
Regulation 868.5790
0510(k)s in 12 months (32 all time)
0recalls in 12 months (16 all time)
6recalls that name a 510(k)
Top companies in BSR
| Company | 510(k)s | Recalls |
|---|---|---|
| Vital Signs Colorado Inc. | 0 | 5 |
| Smiths Medical ASD, Inc | 0 | 4 |
| Teleflex Medical | 0 | 4 |
| Augustine Medical, Inc. | 3 | 0 |
| Scientific Sales Intl., Inc. | 3 | 0 |
| Ackrad Laboratories | 2 | 0 |
| Laerdal Medical Corp. | 2 | 0 |
| Polamedco, Inc. | 2 | 0 |
| Stebar Instrument Corp. | 2 | 0 |
| Aaron Medical, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2024 | Smiths Medical ASD, Inc. smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76 Open, Classified |
BSR | None listed |
| Nov 25, 2024 | Smiths Medical ASD, Inc. smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP Open, Classified |
BSR | None listed |
| Nov 25, 2024 | Smiths Medical ASD, Inc. smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP Open, Classified |
BSR | None listed |
| May 11, 2017 | Teleflex Medical Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel and aluminum rods that are coated with a blue PVC or polypropylene outer covering Open, Classified |
BSR | None listed |
| Oct 11, 2016 | Brathwaites Oliver Medical The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology. Terminated |
BSR | None listed |
| Nov 6, 2015 | Teleflex Medical Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical. Terminated |
BSR | None listed |
| Nov 6, 2015 | Teleflex Medical Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical. Terminated |
BSR | None listed |
| Apr 30, 2015 | Vital Signs Colorado Inc. Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure. Terminated |
BSR | K944729 |
| Apr 30, 2015 | Vital Signs Colorado Inc. CareFusion Vital Signs LightWand Stylet.
A device inserted into an endotracheal tube to aid in the intubation procedure. Terminated |
BSR | K944729 |
| Feb 4, 2015 | Cardinal Health Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pe Terminated |
BSR | None listed |
| Jan 11, 2012 | Teleflex Medical Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex Medical Sdn Bhd, P.O. Box, Industrial Estate, 24600 Kamunting, Perak, Malaysia.
Used temporarily Terminated |
BSR | None listed |
| Sep 21, 2008 | Vital Signs Colorado Inc. Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5 lighted stylets per pack. Terminated |
BSR | K944729 |
| Sep 21, 2008 | Vital Signs Colorado Inc. Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Englewood, CO 80112. Contains one lighted stylet per pack. Terminated |
BSR | K944729 |
| Sep 21, 2008 | Vital Signs Colorado Inc. Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile, Vital Signs Colorado Inc., Englewood, CO. , packaged 20 per case. Terminated |
BSR | K944729 |
| Aug 24, 2006 | Nellcor Puritan Bennett Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20 Terminated |
BSR | None listed |
| Jul 20, 2004 | Smiths Medical ASD, Inc Portex Tracheal Tube Guide 15 Fr, non-sterile
Catalog Number: 153013 Terminated |
BSR | K902180 |
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