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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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Lutech - B299750L0

Multi-parameter patient monitor. 750-L
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750L0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Audioscan - B161VERIFITVF20

No Description
Etymonic Design Incorporated
Verifit VF-2
In Commercial Distribution

  • B161VERIFITVF20 ()
  • B161VERIFITVF23 ()


  • Audiometric/hearing aid tester

Audioscan - B161RM500SL0

The RM500SL is a portable hearing aid analyzer intended to be used by hearing care professionals such as audiologists and hearing aid specialists to verify the electro-acoustic performance of a hearing aid connected to a standard earphone coupler or while worn on the ear of the end user.
Etymonic Design Incorporated
RM500SL
In Commercial Distribution

  • B161RM500SL3 ()
  • B161RM500SL0 ()


  • Audiometric/hearing aid tester

Audioscan Probe Tube - B161RE3670

Molded probe tube, consisting of a thin silicone tube, molded collar, and adjustable ring marker.
Etymonic Design Incorporated
RE367
In Commercial Distribution

  • B161RE3670 ()
  • B161RE3671 ()
RE367-40

  • Audiometric/hearing aid tester

Audioscan - B161AXIOM0

No Description
Etymonic Design Incorporated
Axiom
In Commercial Distribution

  • B161AXIOM3 ()
  • B161AXIOM0 ()


  • Audiometric/hearing aid tester

MINIVAC - B366EP100

EP100
Ecleris
R02
In Commercial Distribution

  • B366EP100 ()
EP100

  • Electroporation therapy system

Sun Nuclear Mammo 156D Stereo Phantom - B136156D0

No Description
SUN NUCLEAR CORP.
156D
In Commercial Distribution

  • B136156D0 ()


  • Mammographic x-ray phantom, test object

Sun Nuclear Mammo 156 Phantom - B1361560

No Description
SUN NUCLEAR CORP.
156
In Commercial Distribution

  • B1361560 ()


  • Mammographic x-ray phantom, test object

WebPAX® - B127WP90

WebPAX® is intended for use in the communication and storage of medical images. WebPAX® is also intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations.
HEART IMAGING TECHNOLOGIES, LLC
9
In Commercial Distribution

  • B127WP90 ()
n/a

  • Medical image management system

DATA MANAGEMENT SYSTEM - B059DMS3500003

Software-as-a-Service Diabetes Data Management Service. System extracts information from BGMs and formats reports of the blood glucose data.
SWEETSPOT DIABETES CARE, INC.
350-0003
Not in Commercial Distribution

  • B059DMS3500003 ()
SSDMS

  • Noninvasive interstitial-fluid glucose monitoring device
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