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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The Scalar Wave Laser System is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
STELLAR LASERS LLC
600100
In Commercial Distribution

  • B3926001000 ()


  • Musculoskeletal/physical therapy laser, home-use
The Vevazz is a device that emits energy in the infrared spectrum and is to be used to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, stiffness or muscle spasms; the temporary increasing of local blood circulation and/or the temporary relaxation of muscle.
VEVAZZ LLC
Vevazz LCD
In Commercial Distribution

  • B552VEVAZZLCD0 ()


  • Musculoskeletal/physical therapy laser, home-use
Pro3M Laser Unit
LZR7, INC.
Pro3M
In Commercial Distribution

  • B657002 ()


  • Musculoskeletal/physical therapy laser, home-use
ZX2 Laser Unit
LZR7, INC.
ZX2
In Commercial Distribution

  • B657001 ()


  • Musculoskeletal/physical therapy laser, home-use
Diag. Station - Ophthal & Oto LED, Spec Dispenser, Pred. Therm, on Mobile Stand Diagnostic Station Wall Mount, Ophthal & Oto LED (DI 00697077001353) 3000 AD Electronic Thermometer (DI 20884521008509)
Amico Diagnostic Incorporated
DS-UR1-CLFL-DXO
In Commercial Distribution

  • 00697077002299 ()


  • Intermittent electronic patient thermometer
  • Direct ophthalmoscope
Diag. Station -Oph & Oto, Disp. Thermometer, Horizontal Mount Diagnostic Station Wall Mount, Ophthal & Oto Halogen (DI 00697077001285) 3000 AD Electronic Thermometer (DI 20884521008509)
Amico Diagnostic Incorporated
DS-UA1-CHFH-DXO
In Commercial Distribution

  • 00697077001124 ()


  • Intermittent electronic patient thermometer
  • Direct ophthalmoscope
Diag. Station -Oph & Oto Hal, Spec. Disp., Oral Therm, Maple Wall brd Diagnostic Station Wall Mount, Ophthal & Oto Halogen (DI 00697077001285) 3000 AD Electronic Thermometer (DI 20884521008509)
Amico Diagnostic Incorporated
DS-UHM-CHFH-DXO
In Commercial Distribution

  • 00697077002251 ()


  • Intermittent electronic patient thermometer
  • Direct ophthalmoscope
Diag. Station -Oph & Oto, LED, Spec Disp, Therm, Grey Wall Brd Diagnostic Station Wall Mount, Ophthal & Oto LED (DI 00697077001353) 3000 AD Electronic Thermometer (DI 20884521008509)
Amico Diagnostic Incorporated
DS-ULG-CLFL-DXO
In Commercial Distribution

  • 00697077001582 ()


  • Intermittent electronic patient thermometer
  • Direct ophthalmoscope
Diag. Station -Hal Oph & Oto, Spec. Dispenser, Predictive Therm, Grey Wall board Diagnostic Station Wall Mount, Ophthal & Oto Halogen (DI 00697077001285) 3000 AD Electronic Thermometer (DI 20884521008509)
Amico Diagnostic Incorporated
DS-ULG-CHFH-DXO
In Commercial Distribution

  • 00697077001520 ()


  • Intermittent electronic patient thermometer
  • Direct ophthalmoscope
Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED light & Microcurrent Massage Microcurrent: indicated for facial stimulation RED+IR: indicated for treat periorbital wrinkle
Foreo AB
Pink
In Commercial Distribution

  • 07350120791245 ()


  • Blue/red/infrared phototherapy lamp
  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED light & Microcurrent Massage Microcurrent: indicated for facial stimulation RED+IR: indicated for treat periorbital wrinkle
Foreo AB
Lavender
In Commercial Distribution

  • 07350120791238 ()


  • Blue/red/infrared phototherapy lamp
  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
VISION RT LIMITED
AlignRT
Not in Commercial Distribution

  • B120ALIGNRT0 ()
AlignRT

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
Central Server host PC Luna 3D
In Commercial Distribution

  • 04260590372659 ()
0018439-0001

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA SGRT PC
In Commercial Distribution

  • 04260590372642 ()
0018346-0003

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA SGRT PC
In Commercial Distribution

  • 04260590372635 ()
0018346-0002

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Central Server Software
In Commercial Distribution

  • 04260590372628 ()
0018440

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Workstation Software
In Commercial Distribution

  • 04260590372611 ()
0018438

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Camera Pod
Not in Commercial Distribution

  • 04260590372604 ()
0018914

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Distribution Box
In Commercial Distribution

  • 04260590372598 ()
0018364-0009

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Distribution Box
In Commercial Distribution

  • 04260590372581 ()
0018364-0008

  • Radiological video camera patient positioning/tracking system
No Description
DIERS International GmbH
n/a
In Commercial Distribution

  • 04260242060194 ()


  • Radiological video camera patient positioning/tracking system
No Description
DIERS International GmbH
II
In Commercial Distribution

  • 04260242060101 ()


  • Radiological video camera patient positioning/tracking system
No Description
DIERS International GmbH
III 4D
In Commercial Distribution

  • 04260242060019 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
HP Z2 G9 workstation - AlignRT Offline
In Commercial Distribution

  • 05056190500986 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
HP Z2 G9 workstation - Patient Data Workstation
In Commercial Distribution

  • 05056190500979 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
HP Z2 G9 workstation - SimRT
In Commercial Distribution

  • 05056190500962 ()


  • Radiological video camera patient positioning/tracking system
DoseRT reference board used with AlignRT Plus systems.
VISION RT LIMITED
DoseRT reference board
In Commercial Distribution

  • 05056190500894 ()
DoseRT reference board

  • Radiological video camera patient positioning/tracking system
Calibration Cube Mk2
VISION RT LIMITED
Calibration Cube Mk2
In Commercial Distribution

  • 05056190500863 ()


  • Radiological video camera patient positioning/tracking system
AlignRT 6.2 software
VISION RT LIMITED
AlignRT 6.2
Not in Commercial Distribution

  • 05056190500818 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Varian ProBeam Hold - Switch Box
In Commercial Distribution

  • 05056190500795 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Real Time Coach
In Commercial Distribution

  • 05056190500788 ()


  • Radiological video camera patient positioning/tracking system
DoseRT camera used for AlignRT Plus systems.
VISION RT LIMITED
DoseRT camera
In Commercial Distribution

  • 05056190500740 ()
DoseRT camera

  • Radiological video camera patient positioning/tracking system
Respiratory Module software module.
VISION RT LIMITED
Respiratory Module
Not in Commercial Distribution

  • 05056190500733 ()
Respiratory Module

  • Radiological video camera patient positioning/tracking system
AlignRT 7.3 (software) used on AlignRT Plus systems
VISION RT LIMITED
AlignRT 7.3 (software)
In Commercial Distribution

  • 05056190500726 ()
AlignRT 7.3 (software)

  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Calibration Plate Narrow
In Commercial Distribution

  • 05056190500719 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Calibration Plate
In Commercial Distribution

  • 05056190500696 ()


  • Radiological video camera patient positioning/tracking system
AlignRT 6.3 software
VISION RT LIMITED
AlignRT 6.3
In Commercial Distribution

  • 05056190500689 ()


  • Radiological video camera patient positioning/tracking system
Touchless4D version 7.2
VISION RT LIMITED
Touchless4D
In Commercial Distribution

  • 05056190500672 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Fujitsu M7010X
In Commercial Distribution

  • 05056190500665 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
AlignRT InBore 7.0
In Commercial Distribution

  • 05056190500641 ()


  • Radiological video camera patient positioning/tracking system
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