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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An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system, platinum, w/ C&V indication
In Commercial Distribution

  • 00647529003893 ()
7200854-09

  • Dental solid-state laser system
A laser system intended for a variety of surgical and oral soft-tissue procedures and dental tooth whitening. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two surgical handpieces and laser tips, a wireless footswitch and other accessories (power cords, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
Dental soft tissue diode laser system refurbished
In Commercial Distribution

  • 00647529003473 ()
7410001P

  • Dental diode laser system
A laser system intended for a variety of surgical and oral soft-tissue procedures and dental tooth whitening. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two surgical handpieces and laser tips, a wireless footswitch and other accessories (power cords, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7410001
In Commercial Distribution

  • 00647529002605 ()
7410001

  • Dental diode laser system
An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip holders, tip cleaning kits). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7200854-05 Refurbished
In Commercial Distribution

  • 00647529002384 ()


  • Dental solid-state laser system
An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7200854-09
In Commercial Distribution

  • 00647529000076 ()
7200854-09

  • Dental solid-state laser system
An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system, platinum, premier
In Commercial Distribution

  • 00647529004401 ()
7200854-209

  • Dental solid-state laser system
A handpiece for a dental 980nm diode laser system intended for a variety of soft-tissue procedures. The dental diode laser system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two handpieces and laser tips, a wireless foot-switch and other accessories (power cord, protective eyewear, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
Handpiece, 1pk
In Commercial Distribution

  • 00647529004159 ()
7420006

  • Dental diode laser system
A handpiece utilized with an all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
Fractional Handpiece Kit
In Commercial Distribution

  • 00647529003770 ()
  • 00647529003756 ()
7220002

  • Dental solid-state laser system
A handpiece utilized with an all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
Fractional Handpiece Kit
In Commercial Distribution

  • 00647529003633 ()
7220002

  • Dental solid-state laser system
An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7200854-03 Refurbished
In Commercial Distribution

  • 00647529002360 ()


  • Dental solid-state laser system
The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen.
FOTONA d.o.o.
M321-A
In Commercial Distribution

  • 03830054230392 ()


  • Dental solid-state laser system
  • General/multiple surgical solid-state laser system
  • Multi-modality skin surface treatment system generator
  • Dermatological solid-state laser system
The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen.
FOTONA d.o.o.
M321-B
In Commercial Distribution

  • 03830054230408 ()


  • Dental solid-state laser system
  • General/multiple surgical solid-state laser system
  • Multi-modality skin surface treatment system generator
  • Dermatological solid-state laser system
The portable and fully digital X-ray system Amadeo M-DR mini is for use for first aid services, intensive care units, emergency departments, as well as ships and mobile hospitals (e.g. container solutions) in inaccessible areas, in laboratories and scientific stations in remote parts of the world. The Amadeo M-DR mini is used for wireless digital X-ray imaging. The Amadeo M-AX Version does not contain wireless flat panel detector.
Oehm und Rehbein GmbH
Amadeo M-AX
Not in Commercial Distribution

  • 04250802902910 ()
  • 04250802902880 ()

  • Weight: 79 Kilogram
AM1000

  • Mobile basic diagnostic x-ray system, digital
The portable and fully digital X-ray system Amadeo M-DR mini is for use for first aid services, intensive care units, emergency departments, as well as ships and mobile hospitals (e.g. container solutions) in inaccessible areas, in laboratories and scientific stations in remote parts of the world. The Amadeo M-DR mini is used for wireless digital X-ray imaging. The Amadeo M-AX Version does not contain wireless flat panel detector.
Oehm und Rehbein GmbH
Amadeo M-AX
In Commercial Distribution

  • 04250802900008 ()

  • Weight: 79 Kilogram
AM1000

  • Mobile basic diagnostic x-ray system, digital
The 8000 Hearing Aid Test System performs a broad range of hearing aid measurements from basic, everyday tests of distortion, battery current drain, and frequency response to advanced tests of digital processing delay and phase. The FONIX 8000 is composed of a main electronics module with a front panel for controlling the operation of the analyzer and a wide-format thermal printer. An external video monitor is used to view test results.
FRYE ELECTRONICS, INC.
8000
In Commercial Distribution

  • FONIX8000 ()


  • Hearing aid tester, electrical
RadmediX AcuityUDR combines components into a complete stationary x-ray system, including tube stand, tube head, collimator, generator, a digital radiography panel, and image acquisition software. 21CFR 892.1680 Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220522 ()


  • Stationary basic diagnostic x-ray system, digital
Scooter, Model: R-100 It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. The Scooter (Models: R-100) is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk, but suffer from mobility limitations. It has a base with aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a control panel, an electric motor, an electromagnetic brake, a rechargeable battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the direction control lever, speed control switch and handle on the control panel. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually.
Yongkang Dingchang Industry&Trade Co., Ltd.
R100
In Commercial Distribution

  • 06975991680019 ()


  • Assistive scooter, electric-motor-driven
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; International power cord; Z200+ thermal printer (includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094324211 ()
XSCRIBE-6AC-DDBAX

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU, no display; No power cord; Z200+ thermal printer (includes starter pack of full-grid paper - 8"), XScribe basic transport cart with base, back panel, and keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global;
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094321081 ()
XSCRIBE-6AB-XCAAA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress- ver 6 w/ adult & pediatric interp; includes current sfw CD & User Manual CD; AM12 Wired Acquisition Module; Turnkey system w/ configured CPU & color LCD 24" monitor w/ 1920 x 1080 res; International pwr cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart w/ base, back panel, & keyboard tray; IEC 10 wire, 12-lead set w/ medi-clips; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094320176 ()
XSCRIBE-6DD-DDBAB

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; UK power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094317534 ()
XSCRIBE-6BC-CDBAA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; International power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094316926 ()
XSCRIBE-6AA-DDBAB

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; International power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094314557 ()
XSCRIBE-6AA-DDBAA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output and RScribe with Interpretation; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; International power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094314168 ()
XSCRIBE-6ED-DDBAA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; US/Canada power cord; Z200+ thermal printer (includes starter pack of full-grid paper - 8"), XScribe basic transport cart with base, back panel, and keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094301120 ()
XSCRIBE-6AC-ACAAX

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; Australia power cord; Z200+ thermal printer (includes starter pack of full-grid paper - 8"), XScribe basic transport cart with base, back panel, and keyboard tray; AHA 10 wir
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094299915 ()
XSCRIBE-6AA-BCAAB

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; No power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Report Export + XML Orders (required for HL7 inter
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094296587 ()
XSCRIBE-6AC-XDBXA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module and RScribe with Interpretation; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; UK power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transfo
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094295429 ()
XSCRIBE-6GD-CDBAB

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output and RScribe with Interpretation; Turnkey system with configured CPU, no display; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirection
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259315 ()
XSCRIBE-6EB-DEBAB

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output and RScribe with Interpretation; Software kit; International power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259308 ()
XSCRIBE-6EC-DDBAB

  • Cardiopulmonary stress exercise monitoring system computer
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