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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Sample Collection Kit, Blood (Adx Single), Heart Health Panel
Cue Health Inc.
C2224
In Commercial Distribution

  • 00810040820984 ()


  • Capillary blood collection kit IVD
OEC Elite MiniView C-Arm Drape – 13 cm Flat Panel
EXACT MEDICAL MANUFACTURING, INC.
E6066
In Commercial Distribution

  • 26975424196210 ()
  • 06975424196216 ()
E6066

  • Medical equipment/instrument drape, single-use
The DR-ID 1836SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1836 SE E
In Commercial Distribution

  • 04547410483420 ()

  • 460x850x15mm


  • Stationary basic diagnostic x-ray system, digital
POS and NEG external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens included in BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, BIOFIRE SPOTFIRE R/ST Panel and BIOFIRE SPOTFIRE R/ST Panel Mini
Mmqci
v.00
In Commercial Distribution

  • 00852720008145 ()
M425

  • Multiple-genus respiratory virus nucleic acid IVD, control
SureSmile Dr Starter Kit
DENTSPLY SIRONA ORTHODONTICS INC.
ORX00001
Not in Commercial Distribution

  • D746ORX000010 ()
  • D746ORX000011 ()
ORX00001

  • Dental abrasive strip, reusable
  • Dental delivery system instrument unit, pneumatic
The Single Flat Panel Monitor, Light Head with Video, Single Flat Panel Monitor-G Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995166731 ()
LGH00037

  • Medical monitor/light mount
CT thyroid shield
F&L Medical Products LLC
Standard
In Commercial Distribution

  • 00860010574591 ()


  • Radiation shielding panel, portable/mobile
  • Radiation shielding collar
CT eye shield
F&L Medical Products LLC
Standard
In Commercial Distribution

  • 00860010574584 ()


  • Radiation shielding panel, portable/mobile
  • Radiation shielding collar
CT breast shield large
F&L Medical Products LLC
Large
In Commercial Distribution

  • 00860010574577 ()


  • Radiation shielding apron
  • Radiation shielding panel, portable/mobile
CT Breast shield medium
F&L Medical Products LLC
Medium
In Commercial Distribution

  • 00860010574560 ()


  • Radiation shielding apron
  • Radiation shielding panel, portable/mobile
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321374 ()
6101BR Size 2 Replacement

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321367 ()
6101BR Size 1 Replacement

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321350 ()
6100B Size 2

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321343 ()
6100B Size 1

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321336 ()
6101AR Size 2

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321329 ()
6100AR Size 1

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321312 ()
6101A Size 2

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321305 ()
6100A Size 1

  • Dental digital imaging sensor, intraoral
CS-series-FP is a Complete System Flat Panel fluoroscopic Imaging System consisting of a patient table, C-arm positioner, X-ray tube, X-ray generator, Flat Panel Detector and Image Processor. The system is configurable with selectable components i.e. tubes, generators, tables, c-arms and flat panel detectors per customer requirements.
OMEGA MEDICAL IMAGING, LLC
CS-series-FP
In Commercial Distribution

  • 00853901007018 ()


  • Stationary angiographic x-ray system, digital
CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient table, Positioner, X-Ray tube, Image Receptor and Image processor are configurable with interchangeable components that are customer specific resulting in a unit configuration i.e. CS50-P2-G2-T3-I4-A4.
OMEGA MEDICAL IMAGING, LLC
CS50
In Commercial Distribution

  • 00853901007001 ()


  • Stationary angiographic x-ray system, digital
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.17
In Commercial Distribution

  • 00854344007764 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.16
In Commercial Distribution

  • 00854344007757 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.15
In Commercial Distribution

  • 00854344007740 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.14
In Commercial Distribution

  • 00854344007733 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.13
In Commercial Distribution

  • 00854344007726 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.12
In Commercial Distribution

  • 00854344007696 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.10
In Commercial Distribution

  • 00854344007672 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.5.0
In Commercial Distribution

  • 00854344007436 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.2.0
In Commercial Distribution

  • 00854344007405 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
v4.0.1
In Commercial Distribution

  • 00854344007290 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
v4.0.1
In Commercial Distribution

  • 00854344007283 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.1.0
In Commercial Distribution

  • 00854344007221 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus, DR, v3.2
In Commercial Distribution

  • 00854344007184 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR
In Commercial Distribution

  • 00854344007030 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus, DR, v3.1
In Commercial Distribution

  • 00854344007016 ()


  • X-ray system computer, diagnostic, general-purpose
PORTABLE WORKSTATION Wirelessly Transfer Images Directly to PACS, Ultra-light, and Portable, Design tested to handle, water, dust, and splash resistance The DELWORKS FIT portable tablet workstation aims to maximize the portability and efficiency of the DELWORKS software - utilizing it anytime, anywhere.
Del Medical, Inc.
3.0
In Commercial Distribution

  • 00858340006097 ()


  • Diagnostic x-ray digital imaging system workstation
No Description
INFIMED, INC.
3.0
Not in Commercial Distribution

  • 00858086006115 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
Nexus DR
Not in Commercial Distribution

  • 00858086006092 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
AGFA
5520/150
In Commercial Distribution

  • 05414904281321 ()
MBFTK

  • Stationary basic diagnostic x-ray system, digital
No Description
AGFA
1.0.1
In Commercial Distribution

  • 05414904278840 ()
MA45R

  • Radiology DICOM image processing application software
No Description
AGFA
5540/100
In Commercial Distribution

  • 05414904275535 ()
MAVV8

  • Stationary basic diagnostic x-ray system, digital
DR with option for Tomosynthesis
AGFA
5530/100
In Commercial Distribution



  • Stationary basic diagnostic x-ray system, digital
DR 400 5520/200 Automatic
AGFA
5520/200
In Commercial Distribution

  • 05414904217870 ()
58UCJ

  • Stationary basic diagnostic x-ray system, digital
NX 2.0 SOFTWARE
AGFA
2.0.
In Commercial Distribution

  • 05414904217818 ()
E1AMX

  • Radiology DICOM image processing application software
No Description
AGFA
CR MD1.0 GENERAL SET 35X35
In Commercial Distribution

  • 05414904209752 ()

  • Width: 35 Centimeter
  • Length: 35 Centimeter
564S1

  • Digital imaging cassette/phosphor plate
No Description
AGFA
V3.0
In Commercial Distribution

  • 05414904208168 ()
E3M81

  • Radiology DICOM image processing application software
DR 600 SEMI-AUTOMATIC
AGFA
5530/200
In Commercial Distribution

  • 05414904197202 ()
542WK

  • Stationary basic diagnostic x-ray system, digital
DR 600 FULLY AUTOMATIC
AGFA
5530/100
In Commercial Distribution

  • 05414904196298 ()
542VH

  • Stationary basic diagnostic x-ray system, digital
CR HD5.0S GENERAL CASSETTE 18X24 CM
AGFA
CR HD5.0S GENERAL CASSETTE 18X24
In Commercial Distribution

  • 05414904188934 ()

  • Length: 18 Centimeter
  • Width: 24 Centimeter
53L5U

  • Digital imaging cassette
CR HD5.0S GENERAL CASSETTE 24X30 CM
AGFA
CR HD5.0S GENERAL CASSETTE 24X30
In Commercial Distribution

  • 05414904188927 ()

  • Width: 30 Centimeter
  • Length: 24 Centimeter
53L4S

  • Digital imaging cassette
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