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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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SkyPulse - 03830054230927

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. The console allows simultenous attachment of a solid state laser module and a diode module with up to three selectable diode laser wavelengths.
FOTONA d.o.o.
M321-A
In Commercial Distribution

  • 03830054230927 ()


  • Dental solid-state laser system
  • General/multiple surgical solid-state laser system
  • Multi-modality skin surface treatment system generator
  • Dermatological solid-state laser system

StarWalker - 03830054230484

The device is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd:YAG laser beam through a frequency doubling non-linear crystal. The Nd:YAG laser is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing variable spot handpiece. Optionally, the KTP Nd:YAG beam can be guided to a 585nm dye converter handpiece, or to a 650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 nm or a 650 nm wavelength, correspondingly. The user activates laser emission by means of a footswitch. All handpieces are equipped with sensors for automatic detection of a handpiece type and the spot size.
FOTONA d.o.o.
M031-3A/2 PQX
In Commercial Distribution

  • 03830054230484 ()


  • Dermatological frequency-doubled solid-state laser system
  • General/multiple surgical frequency-doubled solid-state laser system

SkyPulse - 03830054230408

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

SkyPulse - 03830054230392

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

EN-Dynamic Leg Extension - 08719992508211

Powered Exercise Equipment
Enraf-Nonius B.V.
1455955
In Commercial Distribution

  • 08719992508211 ()


  • Lower-limb mechanical weight exerciser

EN-Dynamic Abdominal Trainer - 08719992508204

Powered Exercise Equipment
Enraf-Nonius B.V.
1455954
In Commercial Distribution

  • 08719992508204 ()


  • Core-body mechanical weight exerciser

EN-Dynamic Pull Down - 08719992508198

Powered Exercise Equipment
Enraf-Nonius B.V.
1455953
In Commercial Distribution

  • 08719992508198 ()


  • Back pulldown exerciser

EN-Dynamic Back Trainer - 08719992508181

Powered Exercise Equipment
Enraf-Nonius B.V.
1455952
In Commercial Distribution

  • 08719992508181 ()


  • Core-body mechanical weight exerciser

EN-Dynamic Chest Press - 08719992508174

Powered Exercise Equipment
Enraf-Nonius B.V.
1455951
In Commercial Distribution

  • 08719992508174 ()


  • Chest-press exerciser

Manumed ST - 08719992508082

Treatment table intended to support a patient in the desired position for examination or treatment within the physiotherapy, rehabilitation and adjacent disciplines.
Enraf-Nonius B.V.
1560000
In Commercial Distribution

  • 08719992508082 ()


  • Examination/treatment table, line-powered

ManuMax - 08719992508075

Treatment table intended to support a patient in the desired position for examination or treatment within the physiotherapy, rehabilitation and adjacent disciplines.
Enraf-Nonius B.V.
1570000
In Commercial Distribution

  • 08719992508075 ()


  • Examination/treatment table, line-powered

ManuXelect - 08719992508068

Treatment table intended to support a patient in the desired position for examination or treatment within the physiotherapy, rehabilitation and adjacent disciplines.
Enraf-Nonius B.V.
1550000
In Commercial Distribution

  • 08719992508068 ()


  • Examination/treatment table, line-powered

Dynatronics Ultra - 08719992508662

Treatment table intended to support a patient in the desired position for examination or treatment within the physiotherapy, rehabilitation and adjacent disciplines.
Enraf-Nonius B.V.
1550000
In Commercial Distribution

  • 08719992508662 ()


  • Examination/treatment table, line-powered

Manumed - 08719992508525

Treatment table intended to support a patient in the desired position for examination or treatment within the physiotherapy, rehabilitation and adjacent disciplines.
Enraf-Nonius B.V.
5500000
In Commercial Distribution

  • 08719992508525 ()


  • Examination/treatment table, line-powered

EN-Dynamic Rotator - 08719992508327

Powered Exercise Equipment
Enraf-Nonius B.V.
1455966
In Commercial Distribution

  • 08719992508327 ()


  • Core-body mechanical weight exerciser

EN-Dynamic Squat - 08719992508310

Powered Exercise Equipment
Enraf-Nonius B.V.
1455965
In Commercial Distribution

  • 08719992508310 ()


  • Lower-limb mechanical weight exerciser

EN-Dynamic Triceps Dips - 08719992508303

Powered Exercise Equipment
Enraf-Nonius B.V.
1455964
In Commercial Distribution

  • 08719992508303 ()


  • Upper-limb mechanical weight exerciser, lever/pulley-cable

EN-Dynamic Seated Leg Press - 08719992508297

Powered Exercise Equipment
Enraf-Nonius B.V.
1455963
In Commercial Distribution

  • 08719992508297 ()


  • Lower-limb mechanical weight exerciser

EN-Dynamic Seated Leg Curl - 08719992508280

Powered Exercise Equipment
Enraf-Nonius B.V.
1455962
In Commercial Distribution

  • 08719992508280 ()


  • Lower-limb mechanical weight exerciser

EN-Dynamic Total Hip - 08719992508273

Powered Exercise Equipment
Enraf-Nonius B.V.
1455961
In Commercial Distribution

  • 08719992508273 ()


  • Lower-limb mechanical weight exerciser

EN-Dynamic Fly - 08719992508266

Powered Exercise Equipment
Enraf-Nonius B.V.
1455960
In Commercial Distribution

  • 08719992508266 ()


  • Core-body mechanical weight exerciser

EN-Dynamic Abduction - 08719992508259

Powered Exercise Equipment
Enraf-Nonius B.V.
1455959
In Commercial Distribution

  • 08719992508259 ()


  • Lower-limb mechanical weight exerciser

EN-Dynamic Adduction - 08719992508242

Powered Exercise Equipment
Enraf-Nonius B.V.
1455958
In Commercial Distribution

  • 08719992508242 ()


  • Lower-limb mechanical weight exerciser

EN-Dynamic Shoulder Press - 08719992508235

Powered Exercise Equipment
Enraf-Nonius B.V.
1455957
In Commercial Distribution

  • 08719992508235 ()


  • Upper-limb mechanical weight exerciser, lever/pulley-cable

EN-Dynamic Rowing - 08719992508228

Powered Exercise Equipment
Enraf-Nonius B.V.
1455956
In Commercial Distribution

  • 08719992508228 ()


  • Back row exerciser

Sonopuls 190 - 08720618311108

Device for ultrasound therapy
Enraf-Nonius B.V.
1631951
In Commercial Distribution

  • 08720618311108 ()


  • Physical therapy ultrasound system

Sonopuls 190 - 08720618311221

Device for ultrasound therapy
Enraf-Nonius B.V.
1631940
In Commercial Distribution

  • 08720618311221 ()


  • Physical therapy ultrasound system

Endolaser 120 - 08720618311153

Device for low level laser therapy
Enraf-Nonius B.V.
1633931
In Commercial Distribution

  • 08720618311153 ()


  • Musculoskeletal/physical therapy laser, professional

Sonopuls 494 - 08720618311139

Multi-modality (electrical stimulation/ultrasound/low level laser) physical therapy system
Enraf-Nonius B.V.
1498941
In Commercial Distribution

  • 08720618311139 ()


  • Multi-modality physical therapy system, professional-use

I-MAX 3D - 03760262651828

I-MAX 3D CEPH version
OWANDY RADIOLOGY
I-MAX 3D PAN CEPH 110-120V
In Commercial Distribution

  • 03760262651828 ()
9304301011

  • Stationary panoramic/tomographic dental x-ray system, digital

I-MAX 3D - 03760262651804

I-MAX 3D PAN version 100-120V with floor-mounted column
OWANDY RADIOLOGY
I-MAX 3D PAN ONLY FLOOR 100-120V
In Commercial Distribution

  • 03760262651804 ()
9304100011.FL

  • Stationary panoramic/tomographic dental x-ray system, digital

I-MAX - 03760262651637

I-MAX CEPH version with double sensor
OWANDY RADIOLOGY
I-MAX PAN CEPH DOUBLE SENSOR 110-120V
In Commercial Distribution

  • 03760262651637 ()
9304201011.DS

  • Stationary panoramic/tomographic dental x-ray system, digital

I-MAX - 03760262651620

I-MAX CEPH version
OWANDY RADIOLOGY
I-MAX PAN CEPH 110-120V
In Commercial Distribution

  • 03760262651620 ()
9304201011

  • Stationary panoramic/tomographic dental x-ray system, digital

I-MAX - 03760262651606

I-MAX PAN version 100-120V with floor-mounted column
OWANDY RADIOLOGY
I-MAX PAN ONLY FLOOR 100-120V
In Commercial Distribution

  • 03760262651606 ()
9304000011.FL

  • Stationary panoramic/tomographic dental x-ray system, digital

Owandy-RX PRO - 03760262650661

Owandy-RX PRO CORE KIT SC NO BRACKET
OWANDY RADIOLOGY
Owandy-RX PRO CORE KIT SC NO BRACKET
In Commercial Distribution

  • 03760262650661 ()
W0806091

  • Stationary intraoral dental x-ray system, digital

Owandy-RX PRO - 03760262650654

Owandy-RX PRO TOP 110 SHORT CONE, with interface wall plate (16")
OWANDY RADIOLOGY
OWANDY-RX PRO TOP 110 SHORT CONE, INTERF WALL PLATE (16”)
In Commercial Distribution

  • 03760262650654 ()
W0806002

  • Stationary intraoral dental x-ray system, digital

Owandy-RX PRO - 03760262650647

Owandy-RX PRO TOP 80 SHORT CONE, with interface wall plate (16")
OWANDY RADIOLOGY
OWANDY-RX PRO TOP 80 SHORT CONE, INTERF WALL PLATE (16”)
In Commercial Distribution

  • 03760262650647 ()
W0806001

  • Stationary intraoral dental x-ray system, digital

Owandy-RX PRO - 03760262650630

Owandy-RX PRO TOP 40 SHORT CONE, with interface wall plate (16")
OWANDY RADIOLOGY
OWANDY-RX PRO TOP 40 SHORT CONE, INTERF WALL PLATE (16”)
In Commercial Distribution

  • 03760262650630 ()
W0806000

  • Stationary intraoral dental x-ray system, digital

Volta AF-Xplorer - 03770019196038

Cardiac Electrophysiology mapping tool
SUBSTRATE HD
A002
In Commercial Distribution

  • 03770019196038 ()
A002

  • Cardiac mapping system computer

VX1 - 03770019196007

Cardiac Electrophysiology mapping tool
SUBSTRATE HD
A001
In Commercial Distribution

  • 03770019196007 ()
A001

  • Cardiac mapping system computer
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