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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Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
712227
In Commercial Distribution

  • 00884838085688 ()
712227

  • Stationary basic diagnostic x-ray system, digital
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Medical Systems DMC GmbH
712226
In Commercial Distribution

  • 00884838085671 ()
712226

  • Stationary basic diagnostic x-ray system, digital
The DigitalDiagnost C50 is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
DigitalDiagnost C50
Not in Commercial Distribution

  • 00884838082366 ()
712201

  • Stationary basic diagnostic x-ray system, digital
Image-intensified fluoroscopic x-ray system
Philips Medical Systems DMC GmbH
709030
In Commercial Distribution

  • 00884838076747 ()
709030

  • Stationary basic diagnostic x-ray system, digital
The DigitalDiagnost is a high-end digital radiography system, that includes - Accessory-lead apron for Vertical stand; - Additional SkyPlate charger; - Adjustable Straps for Patient Support; - Compression Belt (singles. pull); - Detector Holder for Patient Bed; - Hand grips (Pair of); - Handle for Skyplate Large; - Infusion bottle holder; - Mobile Detector Holder; - Paper roll holder; - Patient Support for Stitching; - Portable Panel Protector; - Remote control holder; - Set of 50 Hygienic Bags large; - Set of 50 Hygienic Bags small; - Side Bar; - Stretch Grip for VS/VM Stand; - Table top support
Philips Medical Systems DMC GmbH
712033
In Commercial Distribution

  • 00884838074521 ()
712033

  • Stationary basic diagnostic x-ray system, digital
The DigitalDiagnost is a high-end digital radiography system, that includes - Accessory-lead apron for Vertical stand; - Additional SkyPlate charger; - Adjustable Straps for Patient Support; - Compression Belt (singles. pull); - Detector Holder for Patient Bed; - Hand grips (Pair of); - Handle for Skyplate Large; - Infusion bottle holder; - Mobile Detector Holder; - Paper roll holder; - Patient Support for Stitching; - Portable Panel Protector; - Remote control holder; - Set of 50 Hygienic Bags large; - Set of 50 Hygienic Bags small; - Side Bar; - Stretch Grip for VS/VM Stand; - Table top support
Philips Medical Systems DMC GmbH
712032
In Commercial Distribution

  • 00884838074514 ()
712032

  • Stationary basic diagnostic x-ray system, digital
Stationary x-ray system
Philips Healthcare (Suzhou) Co., Ltd.
DuraDiagnost
Not in Commercial Distribution

  • 00884838095205 ()
712203

  • Stationary basic diagnostic x-ray system, digital
Digital Diagnostic X-Ray System
OSKO, INC.
ELIAN
In Commercial Distribution

  • 00869126000413 ()


  • Stationary basic diagnostic x-ray system, digital
Digital Diagnostic X-Ray System
OSKO, INC.
RU3000
In Commercial Distribution

  • 00869126000406 ()


  • Stationary basic diagnostic x-ray system, digital
Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM
CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő Részvénytársaság
8612
In Commercial Distribution

  • 05999116186126 ()


  • Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
eXero-dr
In Commercial Distribution

  • 06009880828166 ()
CL-08-0013-H2

  • Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
Xmplar-dr
In Commercial Distribution

  • 06009880828159 ()
CL-08-0015-B2

  • Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
eXero-dr
In Commercial Distribution

  • 06009880828142 ()
CL-08-0013-H4

  • Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full-body, low-dose X-ray scanner which produce digital X-ray images used for diagnosis purpose in both trauma and general radiography cases, as well as forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
Xmplar-dr
In Commercial Distribution

  • 06009880828135 ()
CL-08-0013-A11

  • Stationary basic diagnostic x-ray system, digital
The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiography cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
eXero-dr
In Commercial Distribution

  • 06009880828128 ()
CL-08-0013-H11

  • Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
Xmplar-dr
In Commercial Distribution

  • 06009880828111 ()
CL-08-0015-B1

  • Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
Xmplar-dr
In Commercial Distribution

  • 06009880828104 ()
CL-08-0012-A8

  • Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full body, low dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiology cases, as well as forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
Xmplar-dr
In Commercial Distribution

  • 06009880828098 ()
CL-08-0012

  • Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
eXero-dr
In Commercial Distribution

  • 06009880828081 ()
CL-08-0016-I2

  • Stationary basic diagnostic x-ray system, digital
The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiography cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
eXero-dr
In Commercial Distribution

  • 06009880828074 ()
CL-08-0013-H7

  • Stationary basic diagnostic x-ray system, digital
The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiography cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
eXero-dr
In Commercial Distribution

  • 06009880828067 ()
CL-08-0013-H6

  • Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full body, low dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiology cases, as well as forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
Xmplar-dr
In Commercial Distribution

  • 06009880828036 ()
CL-08-0012-A16

  • Stationary basic diagnostic x-ray system, digital
The DigitalDiagnost is a high-end digital radiography system, that includes - Accessory-lead apron for Vertical stand; - Additional SkyPlate charger; - Adjustable Straps for Patient Support; - Compression Belt (singles. pull); - Detector Holder for Patient Bed; - Hand grips (Pair of); - Handle for Skyplate Large; - Infusion bottle holder; - Mobile Detector Holder; - Paper roll holder; - Patient Support for Stitching; - Portable Panel Protector; - Remote control holder; - Set of 50 Hygienic Bags large; - Set of 50 Hygienic Bags small; - Side Bar; - Stretch Grip for VS/VM Stand; - Table top support
Philips Medical Systems DMC GmbH
712031
In Commercial Distribution

  • 00884838065321 ()
712031

  • Stationary basic diagnostic x-ray system, digital
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
DuraDiagnost
Not in Commercial Distribution

  • 00884838064751 ()
712214

  • Stationary basic diagnostic x-ray system, digital
The DuraDiagnost Compact is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
DuraDiagnost Compact
Not in Commercial Distribution

  • 00884838064737 ()
712213

  • Stationary basic diagnostic x-ray system, digital
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® 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®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®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® TR-20C Dual Channel EMG Trainer
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TR-20C
In Commercial Distribution

  • 00852423006158 ()
8625

  • Psychophysiological biofeedback system
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® TR-10 Single Channel EMG Trainer
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TR-10
In Commercial Distribution

  • 00852423006127 ()
8610

  • Psychophysiological biofeedback system
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
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
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
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
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
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
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
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
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
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
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
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
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
Biofeedback Device
DELSYS, INC.
SP-W11
In Commercial Distribution

  • 00851679007407 ()


  • Psychophysiological biofeedback system
Biofeedback Device
DELSYS, INC.
DS-T04
In Commercial Distribution

  • 00851679007391 ()


  • Psychophysiological biofeedback system
Biofeedback Device.
DELSYS, INC.
SP-W09
In Commercial Distribution

  • 00851679007384 ()


  • Psychophysiological biofeedback system
Biofeedback Device.
DELSYS, INC.
SP-W10
In Commercial Distribution

  • 00851679007377 ()


  • Psychophysiological biofeedback system
Biofeedback Device
DELSYS, INC.
SP-W11
In Commercial Distribution

  • 00851679007360 ()


  • Psychophysiological biofeedback system
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