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Panels › Anesthesiology › Product code JOH · Class 2

Tube Tracheostomy And Tube Cuff

Regulation 868.5800

1510(k)s in 12 months (109 all time)
5recalls in 12 months (131 all time)
114recalls that name a 510(k)
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Top companies in JOH

DateFirm and productCodeLinked 510(k)
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M6FEN, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, MFEN, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, p
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M5.5PLC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions
Terminated
JOHK925615
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, MPLC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, p
Terminated
JOHK925615
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M5.5PDC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions
Terminated
JOHK925615
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M4.0PDC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions
Terminated
JOHK925615
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, MPDC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, p
Terminated
JOHK925615
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M10SCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M9SCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M8SCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M7.5SCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M7SCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M6.5SCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M6SCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M5.5SCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M5SCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, MSCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, p
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.5 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructi
Terminated
JOHK955680
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.0 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructi
Terminated
JOHK955680
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Cuffed Long Pediatric Tracheostomy Tube, 5.5 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructi
Terminated
JOHK955680
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Cuffed Long Pediatric Tracheostomy Tube, 5.0 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructi
Terminated
JOHK955680
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Cuffed Pediatric Tracheostomy Tube, 5.5 PDC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK955680
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Cuffed Pediatric Tracheostomy Tube, 5.0 PDC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK955680
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Cuffed Pediatric Tracheostomy Tube, 4.5 PDC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK955680
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Cuffed Pediatric Tracheostomy Tube, 4.0 PDC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK955680
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 10 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of up
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upp
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upp
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 4 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upp
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube, 10 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube, 8 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube, 6 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Low Pressure Cuffed Tracheostomy Tube, 4 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 FEN-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for b
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 FEN-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for b
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Percutaneous Dual Cannula Tracheostomy Tube, 8 PERC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstru
Terminated
JOHK963732
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Percutaneous Dual Cannula Tracheostomy Tube, 6 PERC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstru
Terminated
JOHK963732
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for byp
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway o
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway o
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway o
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 10 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 8 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper a
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 6 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper a
Terminated
JOHK962173
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 4 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper a
Terminated
JOHK962173
Mar 4, 2009Covidien Limited
Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. The product is provided as
Terminated
JOHK945513

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