940 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radiosurgery to tumors or the targeted tissues.
FDA Recall
Terminated
·TomoTherapy Incorporated·Product code MUJ·January 26, 2011
Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan
FDA Recall
Terminated
·TomoTherapy Incorporated·Product code MUJ·December 1, 2009
Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery message, error message, low Sp02 message, event mark. Measuring range Sp02 0 to 100, pulse rate 20 to 250, measuring accuracy Sp02 +/-2% (70 to 100), pulse rate +/- 2, Sp02 alarm, audible and visible, probe type finger, multi-site, paitent range adult to neonatal, memory function approx. 24 hrs, printer/recorder optional accessory, output RS232 w/optional interface module, power supply 2 AAA batteries, Battery life approx. 48 hrs, size 42x68x20mm, weight 42g.
FDA Recall
Terminated
·Minolta Corp·Product code DQA·November 14, 2003
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 intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code DQA·November 19, 2009
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.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code DQA·November 19, 2009
515B Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code DQA·November 19, 2009
BCI 3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths Medical PM, Inc. For continuous patient monitoring of blood oxygen levels, pulse rate and pulse strength measurements. It is only used in hospital or clinical settings or emergency response environments.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DQA·February 27, 2008
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 software that optimizes its use int he cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable bedside whole blood CO-oximeter that directly measures total hemoglobin concentration and the relative concentrations of oxyhemoglobin carboxyhemoglobin concentration methemoglobin. In addition, oxygen content oxygen capacity and oxygen saturation indices are calculated.
FDA Recall
Terminated
·International Technidyne Corp.·Product code DQA·March 23, 2011
Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 (US) N REFURBISHED, Part Number CS78651
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical
FDA Recall
Terminated
·Oridion Capnography Inc·Product code DQA·July 28, 2007
Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #: 6480-25. The SpO2 Foam Wrap Style (Single Patient Use) Sensors are intended to be used to provide for the measurement of the patient's arterial oxygen saturation and pulse rate when connected to Dixtal Medical Pulse Oximeters.
FDA Recall
Terminated
·Dixtal Medical, Inc.·Product code DQA·May 13, 2009
515B Pulse Oximeter, RS232, Refurbished - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code DQA·November 19, 2009
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 environments.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code DQA·November 19, 2009
Capnostream20 (INTL) M, CS08654
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 M ADULT ICU (CPM), CS08654RA
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018