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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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UNOLOK+ Luer Lock Infusion Set,23 G X ¾" ( 0.60X19MM) 7" TUBE MYCO RE-ORDER # 7001P-23L
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
23G X ¾"
In Commercial Distribution

  • 08903347002350 ()
  • 18903347002357 ()
  • 28903347002354 ()
  • 58903347002355 ()
00235

  • Venous butterfly needle/set
MammoScape is an image viewing software dedicated to breast image display. It is designed to support high performance image reading workflows for the review of high volumes of digital mammography, tomosynthesis, and ultrasound image data (coming from e.g. PACS or scanner) by trained medical professionals. It is intended to be used to display, manipulate, annotate, and export breast images and create reporting information. The software workflow can be individually configured, e.g. to meet the specific requirements of screening or diagnostic purposes.
MeVis BreastCare GmbH & Co. KG
1.1.x
In Commercial Distribution

  • 04262459510028 ()


  • Diagnostic x-ray digital imaging system workstation application software
MammoScape is an image viewing software dedicated to breast image display. It is designed to support high performance image reading workflows for the review of high volumes of digital mammography, tomosynthesis, and ultrasound image data (coming from e.g. PACS or scanner) by trained medical professionals. It is intended to be used to display, manipulate, annotate, and export breast images and create reporting information. The software workflow can be individually configured, e.g. to meet the specific requirements of screening or diagnostic purposes.
MeVis BreastCare GmbH & Co. KG
1.0.x
Not in Commercial Distribution

  • 04262459510011 ()


  • Diagnostic x-ray digital imaging system workstation application software
No Description
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
Navi X
In Commercial Distribution

  • 06971355420062 ()


  • General-purpose ultrasound imaging system
CT LVAS (CT:V) software is a non-invasive image processing technology that utilizes a paired inspiration-expiration CT to quantify and visualize regional and global ventilation within the lungs. The device provides physicians with additional clinical data to support management of pulmonary disease. Quantification and visualizations are provided in the form of a report.
4DMEDICAL LIMITED
1.x
In Commercial Distribution

  • 19356870000021 ()


  • CT system application software
No Description
Changzhou Sifary Medical Technology Co., Ltd.
Ultra X
In Commercial Distribution

  • 06972597781171 ()


  • Ultrasonic dental scaling/debridement system
CADDIE is cloud based artificial intelligence medical device software. CADDIE interfaces with the video feed generated by an endoscopic video processor during a colonoscopy procedure. The software is intended to be used by trained and qualified healthcare professionals as an accompaniment to video endoscopy for the purpose of drawing attention to regions with visual characteristics consistent with colonic mucosal lesions (such as polyps and adenomas). CADDIE analyses the data from the endoscopic video processor in real-time and provides information to aid the endoscopist in detecting suspected colorectal polyps, if they are in the field of view of the endoscope. The areas highlighted by CADDIE are not to be interpreted as definite polyps or adenomas. The responsibility to make a decision as to whether or not a highlighted region contains a polyp or is an adenoma lies with the user. The endoscopist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp and its classification based on their own medical judgement.
ODIN MEDICAL LIMITED
v1.4.x
In Commercial Distribution

  • 15065010840024 ()


  • Endoscopic video image interpretive software
No Description
H & O Equipments SA
CryoProbe X+
In Commercial Distribution

  • 15407008481114 ()
S-HO-CXPRP-02

  • General cryosurgical system, cryogen gas, mechanical
No Description
H & O Equipments SA
CryoProbe X+
In Commercial Distribution

  • 15407008481107 ()
S-HO-CXPRP-01

  • General cryosurgical system, cryogen gas, mechanical
NEEDLE HOLDER TROUTMAN W/LOCK
Bausch & Lomb Incorporated
E3839 X
In Commercial Distribution

  • 00757770429882 ()


  • Suturing needle holder, reusable
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