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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)
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Top companies in NXA

Company510(k)sRecalls
MEDLINE INDUSTRIES, LP - Northfield05
Customed, Inc03
Busse Hospital Disposables, Inc.02
Medline Industries, LP02
Washington-Greene County Branch Pennsylvania Assoc10
DateFirm and productCodeLinked 510(k)
May 7, 2026Medline 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
NXANone listed
Feb 17, 2026Medline 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
NXANone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
Open, Classified
NXANone listed
Dec 5, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
Open, Classified
NXANone listed
Sep 6, 2024MEDLINE 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
NXANone listed
Feb 25, 2024MEDLINE 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
NXANone listed
Jan 3, 2024Busse Hospital Disposables, Inc.
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Open, Classified
NXANone listed
Jan 3, 2024Busse Hospital Disposables, Inc.
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Open, Classified
NXANone listed
Feb 6, 2023MEDLINE INDUSTRIES, LP - Northfield
TRACH PACK. Sterile Procedural Tray.
Open, Classified
NXANone listed
Apr 14, 2016Customed, 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
NXAK925020
Sep 3, 2015Customed, 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
NXAK925020
Dec 16, 2014Customed, 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
NXANone listed

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