7 results · 50ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.

FDA Recall
Terminated ·Hamilton Medical, Inc.·Product code BZO·June 1, 2015

Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.

FDA Recall
Terminated ·Hamilton Medical, Inc.·Product code BZO·June 1, 2015

Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.

FDA Recall
Terminated ·Hamilton Medical, Inc.·Product code BZO·June 1, 2015

Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.

FDA Recall
Terminated ·Toshiba American Medical Systems Inc·Product code MQB·May 12, 2014

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 recordings of electrophysiological (such as EEG) signals. The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patients forehead. BIS technology is used as an adjunct to clinical judgement and training. Reliance on BIS technology alone for intraoperative anesthetic management is not recommended.

FDA Recall
Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code GXY·November 8, 2011

P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.

FDA Recall
Terminated ·SonoSite, Inc.·Product code IYO·September 11, 2013

Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (at least 4 years and older and weighing > 15kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision

FDA Recall
Terminated ·Xhale Assurance, Inc.·Product code DQA·May 8, 2019