ClearanceBrief
Panels › Cardiovascular › Product code DQA · Class 2

Oximeter

Regulation 870.2700

13510(k)s in 12 months (727 all time)
9recalls in 12 months (128 all time)
101recalls that name a 510(k)
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Top companies in DQA

DateFirm and productCodeLinked 510(k)
Jul 31, 2018Oridion Medical 1987 Ltd.
Capnostream20 (US) M TO MASIMO, Part Number CS08750
Terminated
DQAK082268
Jul 31, 2018Oridion Medical 1987 Ltd.
Capnostream20 (US) M W/PRINTER, Part Number CS08659
Terminated
DQAK082268
Jul 31, 2018Oridion Medical 1987 Ltd.
Capnostream20 (US) M, Part Number CS08653
Terminated
DQAK082268
Jul 31, 2018Oridion Medical 1987 Ltd.
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Terminated
DQAK112368
Jul 31, 2018Oridion Medical 1987 Ltd.
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Terminated
DQAK112368
Jul 31, 2018Oridion Medical 1987 Ltd.
CAPNOSTREAM 20 (US) N, Part Number CS08651
Terminated
DQAK082268
Dec 16, 2016Covidien LLC
Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rat
Terminated
DQAK904039
Sep 29, 2016Nonin Medical, Inc
8500M Handheld Pulse Oximeter
Terminated
DQAK893221
Apr 4, 2016Merge Healthcare, Inc.
MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human
Terminated
DQAK090662
Apr 4, 2016Merge Healthcare, Inc.
MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures, and records physio
Terminated
DQAK051212
Apr 4, 2016Merge Healthcare, Inc.
Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac
Terminated
DQAK051212
Nov 25, 2015Masimo Corporation
rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpC
Terminated
DQAK080238
Jul 27, 2015Covidien LP (formerly Nellcor Puritan Bennett Inc.)
OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
Terminated
DQAK123581
Jul 27, 2015Covidien LP (formerly Nellcor Puritan Bennett Inc.)
OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
Terminated
DQAK123581
Dec 31, 2014Nonin Medical, Inc
SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100
Terminated
DQAK132402
Nov 13, 2014Masimo Corporation
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and p
Terminated
DQAK121914
Jun 18, 2014Spacelabs Healthcare Inc
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Terminated
DQAK903702
Apr 29, 2013Masimo Corporation
Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and p
Terminated
DQANone listed
May 19, 2011International Technidyne Corp.
AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced soft
Terminated
DQAK951485
Feb 22, 2011Masimo Corporation
Masimo Hemoglobin Pronto-7 with Rainbow 40 Technology for easy-to-use spot-check testing of hemoglobin (SpHb), SpO2, pulse rate, and perfusion index Pronto-7 rainbow 4D Reusable Sensors are an accesso
Terminated
DQAK100403
Dec 9, 2010Dixtal Medical, Inc.
Dixtal Handheld Pulse Oximetry Model 512 Catalog Number: 9100-00
Terminated
DQAK032949
Dec 9, 2010Dixtal Medical, Inc.
Dixtal Handheld Pulse Oximetry Model 513 Catalog Number: 9300-00
Terminated
DQAK032949
Apr 15, 2010Mindray DS USA, Inc., dba Datascope Patient Monitoring
SmarTemp Probe Covers for use with the VS-800 Monitor; Rx only, Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010, also distributed in boxes of 2000 (10 individual boxes of
Terminated
DQAK072235
Apr 15, 2010Mindray DS USA, Inc., dba Datascope Patient Monitoring
SmarTemp Probe Covers for use with the DPM3 Monitor; Rx only, Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010 also distributed in boxes of 2000 (10 individual boxes of 2
Terminated
DQAK072235
Apr 8, 2010Philips Healthcare Inc.
100-120V 2001 Pulse Oximeter with Mars Nurse Call, Refurbished - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Terminated
DQANone listed
Apr 8, 2010Philips Healthcare Inc.
100-120V 2001 Pulse Oximeter with Mars, Refurbished - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Terminated
DQAK000794
Apr 8, 2010Philips Healthcare Inc.
515B Pulse Oximeter, RS232, Refurbished - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Terminated
DQAK893643
Apr 8, 2010Philips Healthcare Inc.
515B Pulse Oximeter, Refurbished - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Terminated
DQAK893643
Apr 8, 2010Philips Healthcare Inc.
100-120V Oxypleth - 520A Pulse Oximeter, Refurbished - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Terminated
DQAK913516
Apr 8, 2010Philips Healthcare Inc.
Spanish 100-120V 2001 Pulse Oximeter WI - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Terminated
DQAK000794
Apr 8, 2010Philips Healthcare Inc.
100-120V 2001 Pulse Oximeter with Mars Nurse Call - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Terminated
DQAK000794
Apr 8, 2010Philips Healthcare Inc.
100-120V 2001 Pulse Oximeter With Mars - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Terminated
DQAK000794
Apr 8, 2010Philips Healthcare Inc.
Spanish 100-120V 515B Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Terminated
DQAK893643
Apr 8, 2010Philips Healthcare Inc.
100-120V 515B with RS-232 Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Terminated
DQAK893643
Apr 8, 2010Philips Healthcare Inc.
French 100-120V 515B Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Terminated
DQAK893643
Apr 8, 2010Philips Healthcare Inc.
515B Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Terminated
DQAK893643
Apr 8, 2010Philips Healthcare Inc.
Span 100-120V 520A - OxyPleth Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Terminated
DQAK913516
Apr 8, 2010Philips Healthcare Inc.
Japanese 100-120V Oxypleth - 520A Pulse Oximeter- Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Terminated
DQAK913516
Apr 8, 2010Philips Healthcare Inc.
100-120V Oxypleth - 520A Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Terminated
DQAK913516
Apr 8, 2010Philips Healthcare Inc.
Refurbished Tidal Wave SP 715, Refurbished, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/rec
Terminated
DQAK032971
Apr 8, 2010Philips Healthcare Inc.
Resp Profile Monitor, 8100 Cosmo+, Refurbished, Respironics/Philips product. Used to provide spirometric, carbon dioxide and pulse oximetry monitoring during general anesthesia and in the intensive c
Terminated
DQAK032971
Apr 8, 2010Philips Healthcare Inc.
Cosmo Model 7100 SP02 & ETC02 Monitor, Refurbished, Respironics/Philips product. Intended to be used for monitoring end tidal CO2, respiration rate, oxygen saturation and pulse rate in critical monit
Terminated
DQAK920379
Apr 8, 2010Philips Healthcare Inc.
Japanese TidalWave SP 715, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the int
Terminated
DQAK032971
Apr 8, 2010Philips Healthcare Inc.
Tidal Wave Sp Model 715, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the inten
Terminated
DQAK032971
Apr 8, 2010Philips Healthcare Inc.
Japanese TidalWave SP 710, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the int
Terminated
DQAK032971
Apr 8, 2010Philips Healthcare Inc.
TidalWave SP 710, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive ca
Terminated
DQAK032971
Apr 8, 2010Philips Healthcare Inc.
Spanish 100-120V Cosmo - 7100 Capnograp, Respironics/Philips products. Intended to be used for monitoring end tidal CO2, respiration rate, oxygen saturation and pulse rate in critical monitoring envi
Terminated
DQAK920379
Apr 8, 2010Philips Healthcare Inc.
Cosmo - Model 7100 SP02 & ETC02 Monitor, Respironics./Philips product. Intended to be used for monitoring end tidal CO2, respiration rate, oxygen saturation and pulse rate in critical monitoring envi
Terminated
DQAK920379
Apr 8, 2010Philips Healthcare Inc.
Sharn TidalGuard SP 710V, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the inte
Terminated
DQAK032971
Mar 2, 2010Smiths Medical PM, Inc.
BCI 3180 Pulse Oximeter uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 E. Main St., Westfield, PA 16950).
Terminated
DQAK020350

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