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Covidien LP (formerly Nellcor Puritan Bennett Inc.)

7 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide recall (Z-1181-2016)Covidien LP (formerly Nellcor Puritan Bennett Inc.)2016-03-17
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and recall (Z-2329-2015)Covidien LP (formerly Nellcor Puritan Bennett Inc.)2015-08-14
OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot recall (Z-2267-2015)Covidien LP (formerly Nellcor Puritan Bennett Inc.)2015-07-27
OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arteria recall (Z-2268-2015)Covidien LP (formerly Nellcor Puritan Bennett Inc.)2015-07-27
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: recall (Z-1950-2015)Covidien LP (formerly Nellcor Puritan Bennett Inc.)2015-07-09
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Inte recall (Z-1951-2015)Covidien LP (formerly Nellcor Puritan Bennett Inc.)2015-07-09
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Purit recall (Z-1058-2015)Covidien LP (formerly Nellcor Puritan Bennett Inc.)2015-02-05

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Every clearance here is in the API, with alerts when new ones post.