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The standards will apply to neuroaxial applications, breathing systems, enteral applications, urethral and urinary applications and limb cuff inflation applications. Read More
The software includes new functionalities, such as tumor and dose tracking and simultaneous display and contouring of up to 10 imaging studies. Read More
Inadequate CAPA procedures and failure to investigate failures of the CorTemp ingestible core body temperature sensor devices landed devicemaker HQ a Form 483 following a September 2017 FDA inspection of its Palmetto, Florida facility. Read More
Maico Diagnostics received a Form 483 following an October 2017 inspection for its failure to have a formally designated unit to handle complaints, quality audits and procedures for design review. Read More
The software is robust enough to be used in hospitals and clinics, adapting to different settings and varieties of MRI scanners, imaging processes and medical software. Read More
The XStat device uses a syringe-like applicator to inject a group of small, expanding sponges into a wound that swell and exert hemostatic pressure to stop bleeding. Read More