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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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ELIAN - 00869126000413

Digital Diagnostic X-Ray System
OSKO, INC.
ELIAN
In Commercial Distribution

  • 00869126000413 ()


  • Stationary basic diagnostic x-ray system, digital

RU3000 - 00869126000406

Digital Diagnostic X-Ray System
OSKO, INC.
RU3000
In Commercial Distribution

  • 00869126000406 ()


  • Stationary basic diagnostic x-ray system, digital

PXS-710D - 00868162000296

X-Ray System, General Purpose Podiatry
SOURCE-RAY, INC.
PXS-710D
In Commercial Distribution

  • 00868162000296 ()
900100

  • Stationary basic diagnostic x-ray system, digital

OMNERA 300M - 00858340006486

The CM-OTC18M is the version of the OMNERA 300M system which uses an overhead tube crane and does not perform synchronized tracking. This x-ray system can perform a comprehensive range of radiographic procedures.
Del Medical, Inc.
CM-OTC18M
In Commercial Distribution

  • 00858340006486 ()


  • Stationary basic diagnostic x-ray system, digital

D-EVO Suite FSx - 00858340006431

The FM-FMT18M is the version of the D-EVO Suite FSx system which uses a floor mounted tube stand and does not perform tracking. This x-ray system can perform a comprehensive range of radiographic procedures.
Del Medical, Inc.
FM-FMT18M
In Commercial Distribution

  • 00858340006431 ()


  • Stationary basic diagnostic x-ray system, digital

D-EVO Suite FSx - 00858340006424

The FM-FMT18T is the version of the D-EVO Suite FSx system which uses a floor mounted tube stand and performs synchronized tracking. This x-ray system can perform a comprehensive range of radiographic procedures.
Del Medical, Inc.
FM-FMT18T
In Commercial Distribution

  • 00858340006424 ()


  • Stationary basic diagnostic x-ray system, digital

D-EVO Suite FSx - 00858340006417

The FM-OTC18M is the version of the D-EVO Suite FSx system which uses an overhead tube crane and does not perform synchronized tracking. This x-ray system can perform a comprehensive range of radiographic procedures.
Del Medical, Inc.
FM-OTC18M
In Commercial Distribution

  • 00858340006417 ()


  • Stationary basic diagnostic x-ray system, digital

D-EVO Suite FSx - 00858340006400

The FM-OTC18T is the version of the D-EVO Suite FSx system which uses an overhead tube crane and performs synchronized tracking. This x-ray system can perform a comprehensive range of radiographic procedures.
Del Medical, Inc.
FM-OTC18T
In Commercial Distribution

  • 00858340006400 ()


  • Stationary basic diagnostic x-ray system, digital

DMX System - 00858340006370

The DM-FMT is the version of the DMX system which uses a floor mounted tubestand and does not perform synchronized tracking or stitching. This x-ray system can perform a comprehensive range of radiographic procedures.
Del Medical, Inc.
DM-FMT
In Commercial Distribution

  • 00858340006370 ()


  • Stationary basic diagnostic x-ray system, digital

DMX System - 00858340006202

The Straight Arm is an economical and space-efficient X-ray system that can perform a comprehensive range of radiographic procedures. Its flexibility permits imaging of patients sitting or standing, as well as recumbent when optional mobile table is present.
Del Medical, Inc.
DM-SARM
In Commercial Distribution

  • 00858340006202 ()


  • Stationary basic diagnostic x-ray system, digital

DMX System - 00858340006196

The DM-FMT18T is the version of the DMX system which uses a floor mounted tube stand and performs synchronized tracking but not stitching. This x-ray system can perform a comprehensive range of radiographic procedures.
Del Medical, Inc.
DM-FMT18T
In Commercial Distribution

  • 00858340006196 ()


  • Stationary basic diagnostic x-ray system, digital

DMX System - 00858340006189

The DM-FMT18M is the version of the DMX system which uses a floor mounted tube stand and does not perform tracking or stitching. This x-ray system can perform a comprehensive range of radiographic procedures.
Del Medical, Inc.
DM-FMT18M
In Commercial Distribution

  • 00858340006189 ()


  • Stationary basic diagnostic x-ray system, digital

DMX System - 00858340006172

The DM-OTC18M is the version of the DMX system which uses an overhead tube crane and does not perform synchronized tracking or stitching. This x-ray system can perform a comprehensive range of radiographic procedures.
Del Medical, Inc.
DM-OTC18M
In Commercial Distribution

  • 00858340006172 ()


  • Stationary basic diagnostic x-ray system, digital

DMX System - 00858340006165

The DM-OTC18T is the version of the DMX system which uses an overhead tube crane and performs synchronized tracking but does not perform stitching. This x-ray system can perform a comprehensive range of radiographic procedures.
Del Medical, Inc.
DM-OTC18T
In Commercial Distribution

  • 00858340006165 ()


  • Stationary basic diagnostic x-ray system, digital

DMX System - 00858340006158

The DM-OTC18S is a version of the DMX x-ray system which allows for stitching and tracking. This system can perform a comprehensive range of radiographic procedures.
Del Medical, Inc.
DM-OTC18S
In Commercial Distribution

  • 00858340006158 ()


  • Stationary basic diagnostic x-ray system, digital

DMX System - 00858340006073

The DM-FWFC is the version of the DMX x-ray system that utilizes the floor to wall floor to ceiling tube mount (FWFC).
Del Medical, Inc.
DM-FWFC
In Commercial Distribution

  • 00858340006073 ()


  • Stationary basic diagnostic x-ray system, digital

ddR Formula Plus - 00860011334620

Stationary Xray System
Swissray Medical AG
ddR Formula Plus
In Commercial Distribution

  • 00860011334620 ()


  • Stationary basic diagnostic x-ray system, digital

ddR Element - 00860011334613

Stationary Xray System
Swissray Medical AG
ddR Element
In Commercial Distribution

  • 00860011334613 ()


  • Stationary basic diagnostic x-ray system, digital

MiniCAT 2D - 00860008443748

No Description
XORAN TECHNOLOGIES LLC
10031
In Commercial Distribution

  • 00860008443748 ()


  • Stationary basic diagnostic x-ray system, digital

MiniCAT 2D - 00860008443724

The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for use in hospitals, clinics, medical imaging centers, and medical practices.
XORAN TECHNOLOGIES LLC
10035
In Commercial Distribution

  • 00860008443724 ()


  • Stationary basic diagnostic x-ray system, digital

Pathway - 00852423006158

Pathway® TR-20C Dual Channel EMG Trainer
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TR-20C
In Commercial Distribution

  • 00852423006158 ()
8625

  • Psychophysiological biofeedback system

Pathway® - 00852423006141

Pathway® TR-20 Dual Channel EMG Trainer
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TR-20
In Commercial Distribution

  • 00852423006141 ()
8620

  • Psychophysiological biofeedback system

Pathway - 00852423006127

Pathway® TR-10 Single Channel EMG Trainer
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TR-10
In Commercial Distribution

  • 00852423006127 ()
8610

  • Psychophysiological biofeedback system

EMYO® - 00852423006486

EMYO®100S is a Single Channel EMG System for dysphagia rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
EMYO® 100S
In Commercial Distribution

  • 00852423006486 ()
EM100S

  • Psychophysiological biofeedback system

EMYO® - 00852423006479

EMYO® 200S is a dual channel EMG System for dysphagia rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
EMYO® 200S
In Commercial Distribution

  • 00852423006479 ()
EM200S

  • Psychophysiological biofeedback system

EMYO® - 00852423006455

EMYO®100 is a Single Channel EMG System for Adult and Pediatric Pelvic Floor Rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
EMYO®100
In Commercial Distribution

  • 00852423006455 ()
EM100-N

  • Psychophysiological biofeedback system

EMYO® - 00852423006448

EMYO®200 is a Dual Channel EMG System for Adult and Pediatric Pelvic Floor Rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
EMYO®200
In Commercial Distribution

  • 00852423006448 ()
EM200

  • Psychophysiological biofeedback system

Trigno Avanti Sensor, 4-Pack - 00851679007407

Biofeedback Device
DELSYS, INC.
SP-W11
In Commercial Distribution

  • 00851679007407 ()


  • Psychophysiological biofeedback system

Trigno Wireless Biofeedback System - 00851679007391

Biofeedback Device
DELSYS, INC.
DS-T04
In Commercial Distribution

  • 00851679007391 ()


  • Psychophysiological biofeedback system

Trigno Charge-16 - 00851679007384

Biofeedback Device.
DELSYS, INC.
SP-W09
In Commercial Distribution

  • 00851679007384 ()


  • Psychophysiological biofeedback system

Trigno Centro - 00851679007377

Biofeedback Device.
DELSYS, INC.
SP-W10
In Commercial Distribution

  • 00851679007377 ()


  • Psychophysiological biofeedback system

Trigno Avanti Sensor - 00851679007360

Biofeedback Device
DELSYS, INC.
SP-W11
In Commercial Distribution

  • 00851679007360 ()


  • Psychophysiological biofeedback system

Trigno Maize Sensor - 00851679007353

Trigno Wireless Biofeedback System component.
DELSYS, INC.
SP-W06-029
In Commercial Distribution

  • 00851679007353 ()


  • Psychophysiological biofeedback system

Trigno Avanti Duo Sensor - 00851679007346

Trigno System Component
DELSYS, INC.
SP-W06-027
In Commercial Distribution

  • 00851679007346 ()


  • Psychophysiological biofeedback system

Trigno Avanti EKG Biofeedback Sensor - 00851679007339

Trigno System Component
DELSYS, INC.
SP-W06-021
In Commercial Distribution

  • 00851679007339 ()


  • Psychophysiological biofeedback system

Trigno Avanti Load Cell Adapter - 00851679007322

Trigno System Component
DELSYS, INC.
SP-W06-022
In Commercial Distribution

  • 00851679007322 ()


  • Psychophysiological biofeedback system

Trigno Avanti Goniometer Adapter - 00851679007315

Trigno System Component
DELSYS, INC.
SP-W06-023
In Commercial Distribution

  • 00851679007315 ()


  • Psychophysiological biofeedback system

Trigno Avanti Analog Input Adapter - 00851679007308

Trigno System Component
DELSYS, INC.
SP-W06-025
In Commercial Distribution

  • 00851679007308 ()


  • Psychophysiological biofeedback system

Trigno Avanti FSR Adapter - 00851679007292

Trigno System Component
DELSYS, INC.
SP-W06-020
In Commercial Distribution

  • 00851679007292 ()


  • Psychophysiological biofeedback system

Trigno Avanti Spring Contact Adapter - 00851679007285

Trigno System Component
DELSYS, INC.
SP-W06-019
In Commercial Distribution

  • 00851679007285 ()


  • Psychophysiological biofeedback system
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