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
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2014 | Nellcor Puritan Bennett Inc. (dba Covidien LP) Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU. Terminated |
CBK | K131252 |
| Oct 28, 2014 | Nellcor 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 |
CBK | K131252 |
| Aug 14, 2014 | Nellcor 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 |
MWI | K130796 K132604 +1 |
| Aug 14, 2014 | Nellcor 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 |
MWI | K130796 K132604 +1 |
| Jun 20, 2014 | Nellcor 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 |
CBK | K970460 |
| Jun 17, 2014 | Nellcor 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 |
CBK | K970460 |
| May 9, 2014 | Nellcor 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 |
CBK | None listed |
| Jan 24, 2014 | Nellcor 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 |
CBK | K964540 K970460 +2 |
| Jan 24, 2014 | Nellcor 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 |
CBK | K964540 K970460 +2 |
| Aug 29, 2012 | Nellcor 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 |
GEI | K030697 K973297 |
| Aug 10, 2012 | Nellcor 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 |
JOH | K962173 |
| Jan 26, 2012 | Nellcor 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 |
GXY | K062692 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K925615 |
| May 6, 2010 | Nellcor 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 |
JOH | K925615 |
| May 6, 2010 | Nellcor 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 |
JOH | K925615 |
| May 6, 2010 | Nellcor 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 |
JOH | K925615 |
| May 6, 2010 | Nellcor 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 |
JOH | K925615 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K903435 |
| May 6, 2010 | Nellcor 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 |
JOH | K955680 |
| May 6, 2010 | Nellcor 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 |
JOH | K955680 |
| May 6, 2010 | Nellcor 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 |
JOH | K955680 |
| May 6, 2010 | Nellcor 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 |
JOH | K955680 |
| May 6, 2010 | Nellcor 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 |
JOH | K955680 |
| May 6, 2010 | Nellcor 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 |
JOH | K955680 |
| May 6, 2010 | Nellcor 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 |
JOH | K955680 |
| May 6, 2010 | Nellcor 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 |
JOH | K955680 |
| May 6, 2010 | Nellcor 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 |
JOH | K962173 |
| May 6, 2010 | Nellcor 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 |
JOH | K962173 |
| May 6, 2010 | Nellcor 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 |
JOH | K962173 |
| May 6, 2010 | Nellcor 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 |
JOH | K962173 |
| May 6, 2010 | Nellcor 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 |
BTO | K810106 |
| May 6, 2010 | Nellcor 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 |
BTO | K810106 |
Newest 50 of 74.