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Bendini Digitizer Array
Nuvasive, Inc.
1570780
In Commercial Distribution
- 00887517246837 ()
- Spinal rod bending system
Beta Bendini Instrument Base Tray
Nuvasive, Inc.
1592760
In Commercial Distribution
- 00887517246820 ()
- Spinal rod bending system
Bendini Rod Bender, Spinal
Nuvasive, Inc.
1592700
In Commercial Distribution
- 00887517246332 ()
- Spinal rod bending system
Bendini Rod Bender II, Spinal
Nuvasive, Inc.
8210306
In Commercial Distribution
- 00887517193957 ()
- Spinal rod bending system
Bendini Base, Rod Bender II Tray
Nuvasive, Inc.
8210307
In Commercial Distribution
- 00887517221155 ()
- Spinal rod bending system
PULSE Single Patient Reference Array Kit
Nuvasive, Inc.
5050401
In Commercial Distribution
- 00195377051004 ()
- Spinal rod bending system
NuVaMap O.R. Imaging Kit
Nuvasive, Inc.
2060040
In Commercial Distribution
- 00887517590268 ()
- Spinal rod bending system
Bendini Hybrid Pointer
Nuvasive, Inc.
8210301
In Commercial Distribution
- 00887517270207 ()
- Spinal rod bending system
Bendini Pointer, Closed Head
Nuvasive, Inc.
8210008
In Commercial Distribution
- 00887517285294 ()
- Spinal rod bending system
Bendini Guideless Pointer, Adjustable
Nuvasive, Inc.
8210007
In Commercial Distribution
- 00887517285287 ()
- Spinal rod bending system
Bendini Guide Pointer
Nuvasive, Inc.
8210006
In Commercial Distribution
- 00887517285270 ()
- Spinal rod bending system
Bendini Guide Pointer, Adjustable
Nuvasive, Inc.
8210005
In Commercial Distribution
- 00887517285263 ()
- Spinal rod bending system
Bendini Swivel Pointer
Nuvasive, Inc.
8210300
In Commercial Distribution
- 00887517107787 ()
- Spinal rod bending system
Bendini Cable Box
Nuvasive, Inc.
8210010
In Commercial Distribution
- 00887517094698 ()
- Spinal rod bending system
Bendini ASF Pointer
Nuvasive, Inc.
8210314
In Commercial Distribution
- 00887517605078 ()
- Spinal rod bending system
Bendini Adjustable Open Pointer
Nuvasive, Inc.
8210312
In Commercial Distribution
- 00887517605054 ()
- Spinal rod bending system
Bendini Rod Bender OCT, Spinal
Nuvasive, Inc.
8210316
In Commercial Distribution
- 00887517672438 ()
- Spinal rod bending system
Bendini Pointer, OCT Hybrid
Nuvasive, Inc.
8210318
In Commercial Distribution
- 00887517672261 ()
- Spinal rod bending system
Guided Surgery Kit (no tools)
STERNGOLD DENTAL LLC
905881
In Commercial Distribution
- 00841549119088 ()
- Dental/maxillofacial surgical procedure kit, medicated, reusable
INSTALL MEDIA 9735323 ENT TOOLS
MEDTRONIC NAVIGATION, INC.
9735323
In Commercial Distribution
- 00643169485136 ()
- Multi-purpose stereotactic surgery system
ACC KIT LNQTOOL TOOLS USA
MEDTRONIC, INC.
LNQTOOL
In Commercial Distribution
- 00643169508262 ()
- Implantable cardiac monitor
INSTALL MEDIA 9735379 CRANIAL TOOLS
MEDTRONIC NAVIGATION, INC.
9735379
In Commercial Distribution
- 00643169540576 ()
- Neurological stereotactic surgery system
SW 9736041 STEALTHSTATION TOOLS DB
MEDTRONIC NAVIGATION, INC.
9736041
In Commercial Distribution
- 00643169984028 ()
- Multi-purpose stereotactic surgery system
O-Ring DC3 Insertion Tools MP5
SOUTHERN IMPLANTS (PTY) LTD
OR-DC3
In Commercial Distribution
- 06009544040774 ()
- Dental implant suprastructure, temporary, preformed, reusable
FEMORAL HEAD REMOVAL PRY TOOLS
Smith & Nephew, Inc.
71361910
In Commercial Distribution
- 03596010566560 ()
71361910
- Orthopaedic inorganic implant inserter/extractor, reusable
Esteem® Surgical Tools Kit
Envoy Medical Corporation
1216
In Commercial Distribution
- 00812282020542 ()
701216-002
- Fully-implantable middle ear implant system
Instrument tray for dental tools
PRACTICON, INC.
7141914 BLU
In Commercial Distribution
- 00723896015780 ()
7141914 BLU
- Instrument tray, reusable
Instrument tray for dental tools
PRACTICON, INC.
7141914 GRA
In Commercial Distribution
- 00723896015766 ()
7141913 GRA
- Instrument tray, reusable
Instrument tray for dental tools
PRACTICON, INC.
7141913 GRA
In Commercial Distribution
- 00723896015759 ()
7141913 GRA
- Instrument tray, reusable
Instrument tray for dental tools
PRACTICON, INC.
7141912 GRA
In Commercial Distribution
- 00723896015742 ()
7141912 GRA
- Instrument tray, reusable
Instrument tray for dental tools
PRACTICON, INC.
7141914 PUR
In Commercial Distribution
- 00723896015803 ()
7141914 PUR
- Instrument tray, reusable
Instrument tray for dental tools
PRACTICON, INC.
7141914 COR
In Commercial Distribution
- 00723896015797 ()
7141914 COR
- Instrument tray, reusable
Instrument tray for dental tools
PRACTICON, INC.
7141914 GRE
In Commercial Distribution
- 00723896015773 ()
7141914 GRE
- Instrument tray, reusable
No Description
Fujirebio Europe
15687
In Commercial Distribution
- 05414470156870 ()
- Laboratory instrument/analyser application software IVD
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
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
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
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
No Description
MetaSystems Hard & Software GmbH
Microscopic image acquisition
In Commercial Distribution
- 04250406460007 ()
- Laboratory instrument/analyser application software IVD
No Description
MetaSystems Hard & Software GmbH
Medical Device Data System
In Commercial Distribution
- 04250406401000 ()
- Clinical management support software IVD
No Description
MetaSystems Hard & Software GmbH
Karyotyping System
In Commercial Distribution
- 04250406400003 ()
- Karyotyping cell-image analyser IVD
No Description
SWIFT HEALTH SYSTEMS INC.
Digital Engancement
In Commercial Distribution
- 00850018135122 ()
8131
- Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Lower Fitting Kit
In Commercial Distribution
- 00850018135054 ()
85003
- Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Fitting Kit
In Commercial Distribution
- 00850018135047 ()
85000
- Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Upper Fitting Kit
In Commercial Distribution
- 00850018135030 ()
85002
- Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Upper Patient Kit
In Commercial Distribution
- 00850018135016 ()
8111
- Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Standard Patient Kit
In Commercial Distribution
- 00850018135009 ()
8101
- Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Lower Patient Kit
In Commercial Distribution
- 00850018135139 ()
8121
- Orthodontic appliance/positioning tray kit
Orthodontic Software
Orchestrate 3d
1
In Commercial Distribution
- 00860008123404 ()
- Dental milling system, CAD/CAM, chairside
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