Panels › Anesthesiology › Product code NXA · Class 2
Tracheotomy Care Kit
Regulation 868.5800
0510(k)s in 12 months (1 all time)
2recalls in 12 months (12 all time)
2recalls that name a 510(k)
Top companies in NXA
| Company | 510(k)s | Recalls |
|---|---|---|
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 5 |
| Customed, Inc | 0 | 3 |
| Busse Hospital Disposables, Inc. | 0 | 2 |
| Medline Industries, LP | 0 | 2 |
| Washington-Greene County Branch Pennsylvania Assoc | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55;
2) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55A;
3) TRACH TOTE, Model Number:DYNJ85691 Open, Classified |
NXA | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55;
2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A;
3) TRACH TOTE, Model Number: DYNJ85691 Open, Classified |
NXA | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) RHINOPLASTY PACK, Model Number: DYNJ84116A Open, Classified |
NXA | None listed |
| Dec 5, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE convenience kits labeled as:
1) TRACH TOTE, REF DYNJ85691;
2) TRACHEOSTOMY, REF DYNJ902123J Open, Classified |
NXA | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits, labeled as:
1) TRACHEOTOMY TRAY, Pack Number DYNDA1894;
2) TRACHEOSTOMY, Pack Number DYNJ45495G ;
3) TRACH PACK, Pack Number DYNJ46518G ;
4) EH EMERGENCY TRACH TRAY , Pa Open, Classified |
NXA | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as:
a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129;
b) TRACH CARE TRAY, REF DYNDJ1057A;
c) TRACHEOSTOMY CARE KIT, RE Open, Classified |
NXA | None listed |
| Jan 3, 2024 | Busse Hospital Disposables, Inc. Catalog No. 9251R1, 9251R2, 9251R3
TRACHEOSTOMY CARE SET / STERILE - LATEX FREE Open, Classified |
NXA | None listed |
| Jan 3, 2024 | Busse Hospital Disposables, Inc. Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE Open, Classified |
NXA | None listed |
| Feb 6, 2023 | MEDLINE INDUSTRIES, LP - Northfield TRACH PACK. Sterile Procedural Tray. Open, Classified |
NXA | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, Terminated |
NXA | K925020 |
| Sep 3, 2015 | Customed, Inc TRACHEOTOMY CARE KIT CUSTOMED 50/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
NXA | K925020 |
| Dec 16, 2014 | Customed, Inc Tracheotomy Care Kit, Catalog number 900-110.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
NXA | None listed |
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