ClearanceBrief
Company

Nellcor Puritan Bennett Inc. (dba Covidien Ltd)

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
74recalls (0 in 12 months)
73recalls that name a 510(k)

Product codes

CodeDeviceRecords
JOHTube Tracheostomy And Tube Cuff57
CBKVentilator, Continuous, Facility Use7
BTOTube, Tracheostomy (W/Wo Connector)6
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2
GEIElectrosurgical, Cutting & Coagulation & Accessories1
GXYElectrode, Cutaneous1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Dec 9, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Terminated
CBKK131252
Oct 28, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU)
Terminated
CBKK131252
Aug 14, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtua
Terminated
MWIK130796
K132604 +1
Aug 14, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Pat
Terminated
MWIK130796
K132604 +1
Jun 20, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patien
Terminated
CBKK970460
Jun 17, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part
Terminated
CBKK970460
May 9, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and mon
Terminated
CBKNone listed
Jan 24, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen senso
Terminated
CBKK964540
K970460 +2
Jan 24, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient
Terminated
CBKK964540
K970460 +2
Aug 29, 2012Nellcor Puritan Bennett Inc. (dba Covidien LP)
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
Terminated
GEIK030697
K973297
Aug 10, 2012Nellcor Puritan Bennett Inc. (dba Covidien LP)
Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use
Terminated
JOHK962173
Jan 26, 2012Nellcor Puritan Bennett Inc. (dba Covidien LP)
BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. Product Usage: To enable rec
Terminated
GXYK062692
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M8DCT, 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, M6DCT, 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, MDCT, 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, M8LPC, 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, M6LPC, 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, MLPC, 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, M8FEN, 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, 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 Single Cannula Cuffed Tracheostomy Tube, 10 SCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructio
Terminated
BTOK810106
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Single Cannula Cuffed Tracheostomy Tube, 9 SCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstruction
Terminated
BTOK810106

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