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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

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

MiniCAT 2D - 00860290000377

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
10030
In Commercial Distribution

  • 00860290000377 ()


  • 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

RevoluX - 04719892352000

Hand Diagnostic Radiography Imaging System
NANORAY BIOTECH CO., LTD.
NDR705
In Commercial Distribution

  • 04719892352000 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300086

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V17Ce
In Commercial Distribution

  • 04719879300086 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300079

No Description
INNOCARE OPTOELECTRONICS CORPORATION
F14G
In Commercial Distribution

  • 04719879300079 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300062

No Description
INNOCARE OPTOELECTRONICS CORPORATION
F14C
In Commercial Distribution

  • 04719879300062 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300055

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V17Ge
In Commercial Distribution

  • 04719879300055 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300048

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V17G
In Commercial Distribution

  • 04719879300048 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300031

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V17C
In Commercial Distribution

  • 04719879300031 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300024

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V14G
In Commercial Distribution

  • 04719879300024 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300017

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V14C
In Commercial Distribution

  • 04719879300017 ()


  • Stationary basic diagnostic x-ray system, digital

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

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

Trigno Avanti Goniometer Adapter - 00851679007315

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

  • 00851679007315 ()


  • 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 12-inch Snap Lead EMG Sensor - 00851679007261

Trigno System Component
DELSYS, INC.
SP-W06-018B
In Commercial Distribution

  • 00851679007261 ()


  • Psychophysiological biofeedback system

Trigno Avanti Mini Sensor - 00851679007247

Trigno System Component
DELSYS, INC.
SP-W06-024
In Commercial Distribution

  • 00851679007247 ()


  • Psychophysiological biofeedback system

Trigno Galileo Sensor - 00851679007223

Trigno System Component
DELSYS, INC.
SP-W06-017
In Commercial Distribution

  • 00851679007223 ()


  • 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
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