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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KINETIKOS - DRIVEN SOLUTIONS, S.A.
0,1
In Commercial Distribution

  • 05600638781835 ()


  • Biomechanical function analysis/rehabilitation software
The KinetikOS software is a cloud-based software as a medical device (SaMD) that utilizes data generated by various sensors from portable or wearable consumer electronics such as smartphones and smartwatches and provides gait-related data analytics. Gait-related measurements and analytics are provided to compatible 3rd-party software via APIs for displaying data, generating reports, performing further analysis and/or integrating data into their digital health software or apps, for the purpose of monitoring and understanding individual user’s general mobility or gait-related health conditions by qualified healthcare providers.
KINETIKOS - DRIVEN SOLUTIONS, S.A.
0,1
In Commercial Distribution

  • 05600638781828 ()


  • Biomechanical function analysis/rehabilitation software
IVC BIRDIE EVO COMPACT FULL BODY LIFT
INVACARE CORPORATION
BRDCOMPACT
In Commercial Distribution

  • 05600494138743 ()


  • Mobile patient lifting system, electrically-powered
WUNDER RS300 PATIENT SCALE BIRDIE EVO XPLUS
INVACARE CORPORATION
BLS5
In Commercial Distribution

  • 05600494138736 ()


  • Patient sling scale
INVACARE ISA COMPACT STAND-UP LIFT
INVACARE CORPORATION
ISACOMPACT
In Commercial Distribution

  • 05600494138712 ()


  • Mobile patient lifting system, electrically-powered
INVACARE ISA XPLUS STAND-UP LIFT
INVACARE CORPORATION
ISAXPLUS
In Commercial Distribution

  • 05600494138705 ()


  • Mobile patient lifting system, electrically-powered
ETUDE HC Lifting Support Trapeze Kit
INVACARE CORPORATION
ELSP-2093
In Commercial Distribution

  • 05600494135216 ()
ELSP-2093

  • Bed traction frame
Etude Homecare Bed Package
INVACARE CORPORATION
ETUDE-HC
In Commercial Distribution

  • 05600494135001 ()
ETUDE-HC

  • Basic electric home bed
AI4CMR v1.0 is a cloud-hosted service used with any third-party DICOM viewer applicationwhere the DICOM viewer serves as the user interface and the interface to a PACS or scanner forAI4CMR. AI4CMR is implemented as a plug-in to the DICOM viewer by the user andautomatically processes and analyses cardiac MR images received by the DICOM viewer toquantify relevant cardiac function metrics and makes the information available to the user at theuser’s discretion Indications for use: AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
AI4MEDIMAGING - MEDICAL SOLUTIONS, S.A.
v1.0
In Commercial Distribution

  • 05600250059022 ()


  • MRI system application software
PeekMed web is a system that allows healthcare professionals to plan a surgery procedure simulating 2D and 3D environments. In the case of a 3D environment, the healthcare professional can resort to a 3D model generated from a previous imaging study on the patient and 3D digital representations of the implant material to be used during surgery, e.g. screws, fixation plates, or full prosthesis, deriving from several producing companies. The software imports diagnostic imaging studies (e.g. X-rays or Computed Tomography (CT)) from a storage (e.g., CD Rom, local folder). In parallel, there is a database containing digital representations of prosthetic materials (templates) supplied by their respective manufacturers, which offers the possibility of inserting templates during the surgery planning. As PeekMed web is capable of representing the medical images in a 2D and/or 3D environment, performing relevant measurements on those images and also capable of adding templates, it then can perform a total overview of the surgery. Being software it does not interact with any part of the body of the user and/or patient.
PEEK HEALTH, S.A.
v1
In Commercial Distribution

  • 05600120304818 ()


  • Orthopaedic/craniofacial implantation planning software
PeekMed is a system that allows healthcare professionals to plan a surgery procedure simulating various environments, from hybrid (2D/3D) to 3D or 2D environments. In the case of a 3D or hybrid environment, the healthcare professional can resort to a 3D model generated from a previous imaging study on the patient and 3D digital representations of the implant material to be used during surgery, i.e. screws, fixation plates, or full prosthesis, deriving from several producing companies. Being software it does not interact with any part of the body of the user and/or patient.
PEEK HEALTH, S.A.
v2
In Commercial Distribution

  • 05600120304801 ()


  • Orthopaedic/craniofacial implantation planning software
Ultra Low Freezer
B Medical Systems SARL
U201
In Commercial Distribution

  • 05450104551512 ()
991.8643.**

  • Ultralow-temperature laboratory freezer
Pharmacy refrigerator/ freezer
B Medical Systems SARL
PF260
In Commercial Distribution

  • 05450104548390 ()
991.8346.**

  • Pharmacy refrigerator/freezer, mains-powered
Laboratory refrigerator/ freezer
B Medical Systems SARL
LF260
In Commercial Distribution

  • 05450104548383 ()
991.8346.**

  • Laboratory refrigerator/freezer
Blood refrigerator/ Plasma freezer
B Medical Systems SARL
BF261
In Commercial Distribution

  • 05450104548376 ()
991.8346.**

  • Blood refrigerator/freezer
Pharmacy refrigerator
B Medical Systems SARL
P380
In Commercial Distribution

  • 05450104548369 ()
991.8336.**

  • Pharmacy refrigerator
Laboratory refrigerator
B Medical Systems SARL
L380
In Commercial Distribution

  • 05450104548352 ()
991.8336.**

  • Laboratory refrigerator, basic
Blood storage refrigerator
B Medical Systems SARL
B381
In Commercial Distribution

  • 05450104548345 ()
991.8336.**

  • Blood refrigerator
Pharmacy refrigerator
B Medical Systems SARL
P290
In Commercial Distribution

  • 05450104548338 ()
991.8326.**

  • Pharmacy refrigerator
Laboratory refrigerator
B Medical Systems SARL
L290
In Commercial Distribution

  • 05450104548321 ()
991.8326.**

  • Laboratory refrigerator, basic
Blood storage refrigerator
B Medical Systems SARL
B291
In Commercial Distribution

  • 05450104548314 ()
991.8326.**

  • Blood refrigerator
Pharmacy refrigerator
B Medical Systems SARL
P130
In Commercial Distribution

  • 05450104548307 ()
991.8316.**

  • Pharmacy refrigerator
Laboratory refrigerator
B Medical Systems SARL
L130
In Commercial Distribution

  • 05450104548291 ()
991.8316.**

  • Laboratory refrigerator, basic
Blood storage refrigerator
B Medical Systems SARL
B131
In Commercial Distribution

  • 05450104548284 ()
991.8316.**

  • Blood refrigerator
Pharmacy refrigerator
B Medical Systems SARL
P55
In Commercial Distribution

  • 05450104548277 ()
991.8306.**

  • Pharmacy refrigerator
Laboratory refrigerator
B Medical Systems SARL
L55
In Commercial Distribution

  • 05450104548260 ()
991.8306.**

  • Laboratory refrigerator, basic
Blood storage refrigerator
B Medical Systems SARL
B51
In Commercial Distribution

  • 05450104548253 ()
991.8306.**

  • Blood refrigerator
Laboratory freezer
B Medical Systems SARL
F130
In Commercial Distribution

  • 05450104548246 ()
991.8706.**

  • Basic laboratory freezer
Plasma storage freezer
B Medical Systems SARL
F131
In Commercial Distribution

  • 05450104548239 ()
991.8706.**

  • Blood plasma freezer
Plasma contact shock freezer (remote cooling unit)
B Medical Systems SARL
CSF61S
In Commercial Distribution

  • 05450104548031 ()
991.8936.**

  • Rapid-contact laboratory freezer
Laboratory refrigerator
B Medical Systems SARL
L380
Not in Commercial Distribution

  • 05450104546761 ()
991.8336.22

  • Laboratory refrigerator, basic
Blood storage refrigerator
B Medical Systems SARL
B701
Not in Commercial Distribution

  • 05450104545207 ()
991.8226.05

  • Blood refrigerator
Blood storage refrigerator
B Medical Systems SARL
B901
Not in Commercial Distribution

  • 05450104545184 ()
991.8236.05

  • Blood refrigerator
Blood storage refrigerator
B Medical Systems SARL
B401
Not in Commercial Distribution

  • 05450104545177 ()
991.8206.05

  • Blood refrigerator
Blood storage refrigerator
B Medical Systems SARL
B501
Not in Commercial Distribution

  • 05450104545146 ()
991.8216.05

  • Blood refrigerator
Pharmacy refrigerator
B Medical Systems SARL
P900
In Commercial Distribution

  • 05450104544163 ()
991.9136.**

  • Pharmacy refrigerator
Pharmacy refrigerator
B Medical Systems SARL
P700
In Commercial Distribution

  • 05450104544101 ()
991.9126.**

  • Pharmacy refrigerator
Pharmacy refrigerator
B Medical Systems SARL
P500
In Commercial Distribution

  • 05450104544095 ()
991.9116.**

  • Pharmacy refrigerator
Pharmacy refrigerator
B Medical Systems SARL
P400
In Commercial Distribution

  • 05450104544071 ()
991.9106.**

  • Pharmacy refrigerator
Ultra Low Freezer
B Medical Systems SARL
U401
In Commercial Distribution

  • 05450104543920 ()
991.8603.**

  • Ultralow-temperature laboratory freezer
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