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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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IntelliSpace Portal - 00884838073876

IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.
Philips Medical Systems Nederland B.V.
8.x
Not in Commercial Distribution

  • 00884838073876 ()


  • Radiology DICOM image processing application software

Enterprise Viewer - 00884838107595

The Enterprise Viewer is used for image distribution within the enterprise. It is used by clinicians as the primary user interface to view and interact with images. It is also used by Radiologists as a lightweight form to access images where they don’t have access to the complete diagnostic workstations. Enterprise Viewer is accessed through an HTML5 browser either over a desktop or using a capable mobile device.
Philips Medical Systems Nederland B.V.
15.X
In Commercial Distribution

  • 00884838107595 ()
839064

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation

Image Management - 00884838107557

Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems. The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
Philips Medical Systems Nederland B.V.
15.X
In Commercial Distribution

  • 00884838107557 ()
839060

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation

INTELLISPACE™ COGNITION - 00884838098244

No Description
Philips Electronics Nederland B.V.
1.1.X
Not in Commercial Distribution

  • 00884838098244 ()
821401000000

  • Cognitive assessment software

Audyx - 07290017820019

Audyx is an online audiology platform for patients care. It runs on a computing device connected to the Internet as well as to an electro-acoustic system to produce controlled signals to perform audiometric evaluation and to assist in the diagnosis of otological disorders
KOALYS TECHNOLOGIES LTD
2.X
In Commercial Distribution

  • 07290017820019 ()
N/A

  • Tone audiometer

Eighteeth - 06972597781171

No Description
Changzhou Sifary Medical Technology Co., Ltd.
Ultra X
In Commercial Distribution

  • 06972597781171 ()


  • Ultrasonic dental scaling/debridement system

CADDIE - 15065010840024

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

CryoProbe™ - 15407008481114

No Description
H & O Equipments SA
CryoProbe X+
In Commercial Distribution

  • 15407008481114 ()
S-HO-CXPRP-02

  • General cryosurgical system, cryogen gas, mechanical

CryoProbe™ - 15407008481107

No Description
H & O Equipments SA
CryoProbe X+
In Commercial Distribution

  • 15407008481107 ()
S-HO-CXPRP-01

  • General cryosurgical system, cryogen gas, mechanical

Samsung Sleep Apnea Feature (Android OS) - 08806094936889

The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094936889 ()


  • Patient general health self-management software

Samsung Sleep Apnea Feature (Wear OS) - 08806094936872

The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094936872 ()


  • Patient general health self-management software

DAAVLIN - B280864NL4800X0

NEOLUX X 350-48
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution

  • B280864NL4800X0 ()
864NL4800X

  • Ultraviolet phototherapy unit, professional

DAAVLIN - B280864NL4000X0

NEOLUX X 350-40
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution

  • B280864NL4000X0 ()
864NL4000X

  • Ultraviolet phototherapy unit, professional

DAAVLIN - B280864NL2424X0

NEOLUX X 311/350-24/24
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution

  • B280864NL2424X0 ()
864NL2424X

  • Ultraviolet phototherapy unit, professional

DAAVLIN - B280864NL2020X0

NEOLUX X 311/350-20/20
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution

  • B280864NL2020X0 ()
864NL2020X

  • Ultraviolet phototherapy unit, professional

DAAVLIN - B280864NL0048X0

NEOLUX X 311-48
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution

  • B280864NL0048X0 ()
864NL0048X

  • Ultraviolet phototherapy unit, professional

DAAVLIN - B280864NL0040X0

NEOLUX X 311-40
DAAVLIN DISTRIBUTING CO., THE
NEOLUX X
Not in Commercial Distribution

  • B280864NL0040X0 ()
864NL0040X

  • Ultraviolet phototherapy unit, professional

Troutman Needle Holder, Curved - 04058935011659

No Description
Bausch & Lomb GmbH
E3839 X
In Commercial Distribution

  • 04058935011659 ()


  • Suturing needle holder, reusable

Audien Hearing - 00850065060880

No Description
Budget Hearing Aids, LLC
Atom X
In Commercial Distribution

  • 00850065060880 ()


  • Air-conduction hearing aid, canal

Castroviejo Corneal Section Scissors le. - 04058935012045

No Description
Bausch & Lomb GmbH
E3305 X
In Commercial Distribution

  • 04058935012045 ()


  • Corneal scissors, reusable

LensHooke X QC Video (For Semen) - 04719874741099

No Description
BONRAYBIO CO., LTD.
QXB set package-US HT
In Commercial Distribution

  • 04719874741099 ()
X QC Video

  • Sperm concentration indicator IVD, control

LensHooke X QC Video (For Semen) - 04719874741082

No Description
BONRAYBIO CO., LTD.
QXB set package-US BR
In Commercial Distribution

  • 04719874741082 ()
X QC Video

  • Sperm concentration indicator IVD, control

LensHooke X QC Video (For Semen) - 04719874741051

No Description
BONRAYBIO CO., LTD.
QXB V2 package
In Commercial Distribution

  • 04719874741051 ()
X QC Video

  • Sperm concentration indicator IVD, control

LensHooke X QC Video (For Semen) - 04719874741044

No Description
BONRAYBIO CO., LTD.
QXB V1 package
In Commercial Distribution

  • 04719874741044 ()
X QC Video

  • Sperm concentration indicator IVD, control

LensHooke X QC Video (For Semen) - 04719874741037

No Description
BONRAYBIO CO., LTD.
QXB V0 package
In Commercial Distribution

  • 04719874741037 ()
X QC Video

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740900

No Description
BONRAYBIO CO., LTD.
X QC Reticle - L2_BR USA CORP.
In Commercial Distribution

  • 04719874740900 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740894

No Description
BONRAYBIO CO., LTD.
X QC Reticle - L1_BR USA CORP.
In Commercial Distribution

  • 04719874740894 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740887

No Description
BONRAYBIO CO., LTD.
X QC Reticle - L0_BR USA CORP.
In Commercial Distribution

  • 04719874740887 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740870

04719874740887 LensHooke X QC Reticle (For Semen)-L0 04719874740894 LensHooke X QC Reticle (For Semen)-L1 04719874740900 LensHooke X QC Reticle (For Semen)-L2 For BR USA CORP.
BONRAYBIO CO., LTD.
X QC Reticle - 3 in1_BR USA CORP.
In Commercial Distribution

  • 04719874740870 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740863

No Description
BONRAYBIO CO., LTD.
X QC Reticle - L2_US
In Commercial Distribution

  • 04719874740863 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740856

No Description
BONRAYBIO CO., LTD.
X QC Reticle - L1_US
In Commercial Distribution

  • 04719874740856 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740849

No Description
BONRAYBIO CO., LTD.
X QC Reticle - L0_US
In Commercial Distribution

  • 04719874740849 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740832

04719874740849 LensHooke X QC Reticle (For Semen)- L0 04719874740856 LensHooke X QC Reticle (For Semen)- L1 04719874740863 LensHooke X QC Reticle (For Semen)- L2 For US
BONRAYBIO CO., LTD.
X QC Reticle - 3 in1_US
In Commercial Distribution

  • 04719874740832 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

IPD - 08435566640353

IPDmilled Analog Ø 3,5-5,5 NEO 5.DIM.355
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566640353 ()
IPD/6A-AR-00/X

  • Dental implant analog

IPD - 08435566640346

IPDmilled Analog Ø 3,25 NEO 5.DIM.325
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566640346 ()
IPD/6A-AN-00/X

  • Dental implant analog

IPD - 08435566638046

IPDmilled Analog Ø 4,1 I 5.La4.100
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566638046 ()
IPD/BA-AR-00/X

  • Dental implant analog

IPD - 08435566638039

IPDmilled Analog Ø 5,1 K 5.La5.100
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566638039 ()
IPD/AA-AW-00/X

  • Dental implant analog

IPD - 08435566638022

IPDmilled Analog Ø 4,1 K 5.La4.100
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566638022 ()
IPD/AA-AR-00/X

  • Dental implant analog

IPD - 08435566638015

IPDmilled Analog Ø 3,5 K 5.La3.500
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566638015 ()
IPD/AA-AN-00/X

  • Dental implant analog

IPD - 08435566637964

IPDmilled Analog Ø 5,0 MIS 5.La5.000
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566637964 ()
IPD/TA-AW-00/X

  • Dental implant analog
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