Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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OmegaAI Image Viewer is designed to view and manipulate medical images or videos created from diagnostic imaging systems such as X-ray, Computed tomography, Nuclear medicine, MRI, Ultrasound, laboratory systems, and images from other sources such as handheld devices and cameras, endoscopy or other sources of images and videos. It can perform various image manipulation activities and store the modifications as presentation state along with the original study for future reference. OmegaAI Image Viewer allows users to perform image manipulations using the Adjustment Tools, including window level, rotate, flip, pan, stack scroll, and magnify. Notably, users have access to Markup Tools such as annotate, angle, cobb angle, probe, Mark ROI, and measurement. OmegaAI Image Viewer is also capable of organizing all the captured images for a patient and presenting them in a zero-footprint, web user interface, allowing the users to view images in their preferred layout and enabling them to compare current images with prior images of the respective patient.
Ramsoft Inc
2.0
In Commercial Distribution

  • B359OMEGAAIIV021 ()
OMEGAAIIV02

  • Radiology information system application software
  • Radiology picture archiving and communication system workstation
Nerivio is a wireless remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. This prescription device is self-applied to the upper arm and should be used in the home environment at the onset of migraine headache or aura. or every other day for preventive treatment. Nerivio utilizes an endogenous descending analgesic mechanism in which pain in one part of the body inhibits pain in multiple remote body regions (Conditioned Pain Modulation [CPM]). Nerivio is a wireless wearable battery-operated device controlled by a mobile software application. The application has a graphical user interface (GUI) that includes graphical controls that the user can select using a touch screen. This application activates the stimulation, controls the stimulation intensity, monitors the treatment duration, and pauses and terminates the stimulation. The application also provides notifications and indications on the connection state and the remaining number of treatments.
Theranica Bio-Electronics Ltd.
FGD000075
In Commercial Distribution

  • 07290017578019 ()


  • Craniofacial analgesia electrical stimulator
Elite Biomedical Solutions Dose Request Cord is a replacement for the BD Alaris PCA Pump Model 8120 syringe infusion pump. Elite Biomedical Solutions does not manufacture the pump. The Dose Request Cord is an accessory for the pump and is available as a replacement part. The Dose Request Cord contains a handpiece with integral cable which plugs into the mating connector on the BD Alaris PCA Pump to allow the patient to request medication within the parameters entered into the syringe/infusion pump by the healthcare provider and the designed limits on the pumps. The Elite Biomedical Solutions Dose Request Cord has the same type of construction and technological characteristics as the predicate device, which is also a replacement bolus cable. Both the subject and predicate device are equivalent to the accessories supplied with the original pump. The Dose Request Cords are passive devices that contain no powered electronic components. They are powered by the mating equipment using low voltages to detect changes in the state of the push button. Shielding and insulation of these devices is substantially equivalent to the predicate device.
Elite Biomedical Solutions LLC
B
In Commercial Distribution

  • 00860008635402 ()
10013795 EBS

  • Infusion pump remote control
BOISE HEART
MEDLINE INDUSTRIES, INC.
DYNJ905070G
In Commercial Distribution

  • 10195327276904 ()
DYNJ905070G

  • General surgical procedure kit, non-medicated, single-use
BOISE LAP GASTRIC
MEDLINE INDUSTRIES, INC.
DYNJ902224F
In Commercial Distribution

  • 40195327047673 ()
  • 10195327047672 ()
DYNJ902224F

  • General surgical procedure kit, non-medicated, single-use
CTS-BOISE (GARDEN CITY / BTB)
MEDLINE INDUSTRIES, INC.
DYNJ64692B
In Commercial Distribution

  • 40195327312542 ()
  • 10195327312541 ()
DYNJ64692B

  • General surgical procedure kit, non-medicated, single-use
BOISE LAP GASTRIC
MEDLINE INDUSTRIES, INC.
DYNJ902224C
In Commercial Distribution

  • 10889942931422 ()
DYNJ902224C

  • General surgical procedure kit, non-medicated, single-use
BOISE TOTAL KNEE-LF
MEDLINE INDUSTRIES, INC.
DYNJ41528I
In Commercial Distribution

  • 10889942930708 ()
DYNJ41528I

  • General surgical procedure kit, non-medicated, single-use
BOISE TOTAL HIP-LF
MEDLINE INDUSTRIES, INC.
DYNJ41527I
In Commercial Distribution

  • 10889942930692 ()
DYNJ41527I

  • General surgical procedure kit, non-medicated, single-use
BOISE SPINE-LF
MEDLINE INDUSTRIES, INC.
DYNJ41525K
In Commercial Distribution

  • 10889942930685 ()
DYNJ41525K

  • General surgical procedure kit, non-medicated, single-use
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