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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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BIONIX RADIATION THERAPY - 00817740020119

SECURE FIT BAR: HEAD AND NECK
Bionix Radiation Therapy, LLC
UTRT-5012A
Not in Commercial Distribution

  • 00817740020119 ()
UTRT-5012A

  • Vacuum-mould patient positioning system

CALLISTO eye - 04049539104410

No Description
Carl Zeiss Meditec AG
3.7
In Commercial Distribution

  • 04049539104410 ()


  • Operating room audiovisual data/device management system

CALLISTO eye - 04049539104403

No Description
Carl Zeiss Meditec AG
3.6.2
In Commercial Distribution

  • 04049539104403 ()


  • Operating room audiovisual data/device management system

CALLISTO eye - 04049539104366

No Description
Carl Zeiss Meditec AG
CALLISTO eye
In Commercial Distribution

  • 04049539104366 ()


  • Operating room audiovisual data/device management system

CALLISTO eye - 04049539102423

No Description
Carl Zeiss Meditec AG
3.2.1
In Commercial Distribution

  • 04049539102423 ()


  • Operating room audiovisual data/device management system

CALLISTO eye Software - 04049539070302

No Description
Carl Zeiss Meditec AG
5
In Commercial Distribution

  • 04049539070302 ()


  • Operating room audiovisual data/device management system

CALLISTO eye - 04049539069092

No Description
Carl Zeiss Meditec AG
3.5.1
In Commercial Distribution

  • 04049539069092 ()


  • Operating room audiovisual data/device management system

NA - 04055207013441

RIWO-NET SPEECH CONTROL UK-ENG
Richard Wolf GmbH
5590976
Not in Commercial Distribution

  • 04055207013441 ()
5590.976

  • Operating room audiovisual data/device management system

NA - 04055207013434

RIWO-NET SPEECH CONTROL SPAN
Richard Wolf GmbH
5590975
Not in Commercial Distribution

  • 04055207013434 ()
5590.975

  • Operating room audiovisual data/device management system

NA - 04055207013427

RIWO-NET SPEECH CONTROL ITAL
Richard Wolf GmbH
5590974
Not in Commercial Distribution

  • 04055207013427 ()
5590.974

  • Operating room audiovisual data/device management system

NA - 04055207013410

RIWO-NET SPEECH CONTROL FRENCH
Richard Wolf GmbH
5590973
Not in Commercial Distribution

  • 04055207013410 ()
5590.973

  • Operating room audiovisual data/device management system

NA - 04055207013403

RIWO-NET SPEECH CONTROL US-ENG
Richard Wolf GmbH
5590972
Not in Commercial Distribution

  • 04055207013403 ()
5590.972

  • Operating room audiovisual data/device management system

NA - 04055207013397

RIWO-NET SPEECH CONTROL DE
Richard Wolf GmbH
5590971
Not in Commercial Distribution

  • 04055207013397 ()
5590.971

  • Operating room audiovisual data/device management system

NA - 04055207013359

CAN-INTERFACE SERIAL DEVICES reusable
Richard Wolf GmbH
5590817
Not in Commercial Distribution

  • 04055207013359 ()
5590817

  • Operating room audiovisual data/device management system

NA - 04055207013342

CAN-INTERFACE SERIAL DEVICES reusable
Richard Wolf GmbH
5590816
Not in Commercial Distribution

  • 04055207013342 ()
5590.816

  • Operating room audiovisual data/device management system

NA - 04055207013335

CAN-INTERFACE OR-TABLE Interface module allows controlling OR tables of company Trumpf and Maquet. Controllable models Trumpf: Titan, Jupiter, Jupiter, Universal Carbon, Mars, Mars Endouro, Saturn Select, TruSystem 5500, TruSystem 7500 Controllable models Maquet: 1132 Alphastar, 1133 Alphamaxx, 1150 Alphamaquet, 113112 Betastar Dim (WxHxD) in mm: 215 x 38 x 120 WT: 420g, Mains voltage 12V DC / 0,5A Available since core.software release 5.0
Richard Wolf GmbH
5590815
Not in Commercial Distribution

  • 04055207013335 ()
5590.815

  • Operating room audiovisual data/device management system

ScanX Duo Touch - D678J12050

The ScanX is intended to be used for scanning and processing digital images exposed on photostimulable phosphor storage plates in dental applications.
AIR TECHNIQUES, INC.
J1205
In Commercial Distribution

  • D678J12001 ()
  • D678J12050 ()
J1200

  • Dental computed radiography digital imaging scanner

VistaScan Ultra View - D67821701005000

The unit is intended exclusively for use in dental applications for the scanning and processing of image data on an image plate.
AIR TECHNIQUES, INC.
2170100500
In Commercial Distribution

  • D67821701100011 ()
  • D67821701005000 ()


  • Dental computed radiography digital imaging scanner

SYSTEM, X-RAY, STATIONARY - 08809246620032

TITAN 11 is a diagnostic DR System that contains high output capacity and high-resolution image processing system. During a surgery, the presence of lesions, size, and location can be recorded easily as Radiography images. The important images can be stored within the device so taking Radiography images is convenient.
GEMSS MEDICAL SYSTEMS CO.,LTD.
TITAN 11
In Commercial Distribution

  • 08809246620032 ()
TITAN 11

  • Computed radiography digital imaging scanner

Genoray - 08809244060076

No Description
GENORAY CO., LTD.
GenX-CR
In Commercial Distribution

  • 08809244060076 ()


  • Computed radiography digital imaging scanner
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