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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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Sherlock - 00801741121463

Software
Bard Access Systems, Inc.
Sherlockv1.1.1
In Commercial Distribution

  • 00801741121463 ()
Sherlockv1.1.1

  • Central venous catheter navigation system, electrocardiographic/magnetic

Sherlock - 00801741121456

Software
Bard Access Systems, Inc.
Sherlockv1.1.0
In Commercial Distribution

  • 00801741121456 ()
Sherlockv1.1.0

  • Central venous catheter navigation system, electrocardiographic/magnetic

Site-Rite - 00801741121432

Software
Bard Access Systems, Inc.
SR8v1.0.2
In Commercial Distribution

  • 00801741121432 ()
SR8v1.0.2

  • General-purpose ultrasound imaging system

Site-Rite - 00801741121425

Software
Bard Access Systems, Inc.
SR8v1.0.1
In Commercial Distribution

  • 00801741121425 ()
SR8v1.0.1

  • General-purpose ultrasound imaging system

MARS - 00886874119433

Software
INTUITIVE SURGICAL, INC.
610140
In Commercial Distribution

  • 00886874119433 ()


  • Medical video image recorder

LiRAS for LiPA HCV v1 - 05414470156870

No Description
Fujirebio Europe
15687
In Commercial Distribution

  • 05414470156870 ()


  • Laboratory instrument/analyser application software IVD

Caseview - 00883873837788

SOFTWARE, CODE-STAT CASEVIEW SOFTWARE INSTALL
PHYSIO-CONTROL, INC.
21340
In Commercial Distribution

  • 00883873837788 ()
21340-000850

  • Medical equipment clinical data interfacing software

NilRead - 00697978970017

The NilRead software application provides desktop and portable access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data, including mammography and breast tomosynthesis. NilRead also allows users to collaborate by sharing application sessions. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM “for presentation” images must be used. On mobile platforms, this device is not intended for diagnostic use.
Hyland Software Canada ULC
NIL-READ-GLB
In Commercial Distribution

  • 00697978970017 ()


  • Radiological PACS software

PhySoft AMS - 00861858000303

PhySoft AMS™ is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoft AMS™ is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
PHYSICIAN SOFTWARE SYSTEMS, LLC
1
In Commercial Distribution

  • 00861858000303 ()


  • Nephrology information system application software

Preview - B973PREVIEWSHOULDER0

The Preview Shoulder, a 3D total shoulder arthroplasty (TSA) surgical planning software, is a standalone software application which assists the surgeon in planning reverse and anatomic shoulder arthroplasty. Preview Shoulder includes 3D digital representations of implants for placement in images used for surgical planning. Preview Shoulder is a secure software application used by qualified or trained surgeons and is accessed by authorized users. The primary function of Preview Shoulder is to receive and process DICOM CT image(s) of patients. Preview Shoulder can be used to place an implant in the original CT image and place an implant in the 3D model of reconstructed bone. The Preview Shoulder allow the user to perform surgical planning and generate an output surgical report. Preview Shoulder does not provide a diagnosis or surgical recommendation. The surgeon is responsible for selecting and placing the implant model for pre-surgical planning purposes.
Genesis Software Innovations LLC
1.29.1
In Commercial Distribution

  • B973PREVIEWSHOULDER0 ()
PREVIEWSHOULDER

  • Image segmentation application software

ProVoyance PreOp Shoulder - B973PREOPSHOULDER0

The PreOp Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study. The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source. 3D digital representations of various implant models are available in the planning software. Pre-Op Shoulder allows the user to digitally perform the surgical planning by showing a representation of the patient's shoulder anatomy as a 3D model and allows the surgeon to place the implant in the patient's anatomy. The software allows the surgeon to generate a report, detailing the output of the planning activity. Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes. Instructions for use can be found at the following location: https://portal.si.genesisplanningsoftware.com/
Genesis Software Innovations LLC
2
In Commercial Distribution

  • B973PREOPSHOULDER0 ()


  • Image segmentation application software

Metafer - 04250406460007

No Description
MetaSystems Hard & Software GmbH
Microscopic image acquisition
In Commercial Distribution

  • 04250406460007 ()


  • Laboratory instrument/analyser application software IVD

Neon - 04250406401000

No Description
MetaSystems Hard & Software GmbH
Medical Device Data System
In Commercial Distribution

  • 04250406401000 ()


  • Clinical management support software IVD

Ikaros - 04250406400003

No Description
MetaSystems Hard & Software GmbH
Karyotyping System
In Commercial Distribution

  • 04250406400003 ()


  • Karyotyping cell-image analyser IVD

Inbrace Teeth Straightening System - 00850018135139

No Description
SWIFT HEALTH SYSTEMS INC.
Lower Patient Kit
In Commercial Distribution

  • 00850018135139 ()
8121

  • Orthodontic appliance/positioning tray kit

Inbrace Teeth Straightening System - 00850018135122

No Description
SWIFT HEALTH SYSTEMS INC.
Digital Engancement
In Commercial Distribution

  • 00850018135122 ()
8131

  • Orthodontic appliance/positioning tray kit

InBrace Teeth Straightening System (Gen 2.0) - 00850018135054

No Description
SWIFT HEALTH SYSTEMS INC.
Lower Fitting Kit
In Commercial Distribution

  • 00850018135054 ()
85003

  • Orthodontic appliance/positioning tray kit

InBrace Teeth Straightening System (Gen 2.0) - 00850018135047

No Description
SWIFT HEALTH SYSTEMS INC.
Fitting Kit
In Commercial Distribution

  • 00850018135047 ()
85000

  • Orthodontic appliance/positioning tray kit

InBrace Teeth Straightening System (Gen 2.0) - 00850018135030

No Description
SWIFT HEALTH SYSTEMS INC.
Upper Fitting Kit
In Commercial Distribution

  • 00850018135030 ()
85002

  • Orthodontic appliance/positioning tray kit

Inbrace Teeth Straightening System - 00850018135016

No Description
SWIFT HEALTH SYSTEMS INC.
Upper Patient Kit
In Commercial Distribution

  • 00850018135016 ()
8111

  • Orthodontic appliance/positioning tray kit

Inbrace Teeth Straightening System - 00850018135009

No Description
SWIFT HEALTH SYSTEMS INC.
Standard Patient Kit
In Commercial Distribution

  • 00850018135009 ()
8101

  • Orthodontic appliance/positioning tray kit

CS MODEL+ - 00693856000302

LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
Dental Imaging Technologies Corporation
594483
In Commercial Distribution

  • 00693856000302 ()
594483

  • CAD/CAM software

3Shape Ortho System - 05902768365283

3Shape’s Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes only Export Model (also called dental casts), Custom Metal Bands (also called metal bands), and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). All devices are to be fabricated from FDA cleared materials.
3shape A/S
2015-1
Not in Commercial Distribution

  • 05902768365283 ()


  • CAD/CAM software

Automate - 05902729753821

The 3Shape Automate software is a web service for automatic design of crowns
3shape A/S
R1.2
In Commercial Distribution

  • 05902729753821 ()


  • Dental treatment application software

Splint Design - 05902729753555

Dental treatment application software
3shape A/S
R1.0
In Commercial Distribution

  • 05902729753555 ()


  • Dental treatment application software

Ortho System - 05902729753487

Ortho System is a software system intended for use as a medical front-end for orthodontic clinics and laboratories. It supports orthodontic diagnosis, treatment planning and follow-up, CAD modelling of orthodontic appliances and indirect bonding as well as archiving of case information.
3shape A/S
85.x
In Commercial Distribution

  • 05902729753487 ()


  • Dental treatment application software

Ortho System - 05902729752510

CAD/CAM software
3shape A/S
2017-1
Not in Commercial Distribution

  • 05902729752510 ()


  • CAD/CAM software

Automate - 05902729753654

DentalSystem-backed web service for automatic designs of crowns.
3shape Trios A/S
R1.0
Not in Commercial Distribution

  • 05902729753654 ()


  • Dental treatment application software

Splint Design - 05902729752954

Dental treatment application software
3shape A/S
1.1.x
Not in Commercial Distribution

  • 05902729752954 ()


  • Dental treatment application software

Ortho System - 05902729752787

CAD/CAM software
3shape A/S
2018-1
Not in Commercial Distribution

  • 05902729752787 ()


  • CAD/CAM software
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