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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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EVA SELECT DIRECT - D83399924131050

EVA SELECT DIRECT SIZE 1 SENSOR ONLY
ImageWorks
9992413105
In Commercial Distribution

  • D83399924131050 ()
9992413105

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral

EVA SELECT DIRECT - D83399924131000

EVA SELECT DIRECT SIZE 1 SYSTEM
ImageWorks
9992413100
In Commercial Distribution

  • D83399924131000 ()
9992413100

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral

EVA SELECT - D83399924122000

EVA SELECT SIZE 2 SYSTEM
ImageWorks
9992412200
In Commercial Distribution

  • D83399924122000 ()
9992412200

  • General-purpose dental x-ray system application software
  • Dental digital imaging sensor, intraoral

EVA SELECT - D83399924121000

EVA SELECT SIZE 1 SYSTEM
ImageWorks
9992412100
In Commercial Distribution

  • D83399924121000 ()
9992412100

  • Dental digital imaging sensor, intraoral
  • General-purpose dental x-ray system application software

Waya Rehab - G741WHREHABV10

Waya® Rehab is a software only medical device to support rehabilitation under the guidance of a qualified healthcare professional.
WELLOVATE, LLC
1
In Commercial Distribution

  • G741WHREHABV10 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software

OMNI-Lab - G600OL12SP5

OMNI-Lab is a Laboratory Information System (LIS) intended to be used for the management of clinical information. The OMNI-Lab stand-alone software is only used by trained health professionals.
Omnitech Labs Inc.
12 SP5
In Commercial Distribution

  • G600OL12SP5 ()


  • Clinical laboratory information system application software

Nx2me Connected Health Nx2me Clinician Portal - M535NX1225NX1380

No Description
NXSTAGE MEDICAL, INC.
NX1380
Not in Commercial Distribution

  • M535NX1225NX1380 ()


  • Medical equipment clinical data interfacing software

Nx2me Connected Health Nx2me App - M535NX1225NX1379

No Description
NXSTAGE MEDICAL, INC.
NX1379
Not in Commercial Distribution

  • M535NX1225NX1379 ()


  • Medical equipment clinical data interfacing software

UbiqVue - B353UA2251R1

Holter Mobile App
Lifesignals, Inc.
UA2251-R
In Commercial Distribution

  • B353UA2251R1 ()


  • Medical equipment clinical data interfacing software

Sickbay Clinical Platform - B693SICKBAY034400

Sickbay Clinical Platform is a software product that is intended to run on a hospital's secure network. It gathers and stores all the physiological sensor data from patients admitted to the ER or ICU and is capable of re-displaying all the data in near real-time when gathered or at a later time.
Medical Informatics Corp.
3.44.0.0
In Commercial Distribution

  • B693SICKBAY034400 ()


  • Medical equipment clinical data interfacing software
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