4 results
·
6ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Hays Ultrasound kit Item ID: H1000SE
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.
FDA Enforcement
Class II
·Terminated·Pharmacaribe llc·February 17, 2016
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, ECU diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (HI1S) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·September 25, 2013