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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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D-Scope Systems server software enables data and media synchronization features within the client's medical facilities by integrating with the client information system and patient EMR (HL7) and PACS/VNA (DICOM).
D-Scope Systems
6
In Commercial Distribution

  • 00860009377615 ()


  • Endoscopic video image processing unit
D-Scope Systems workstation software is a hardware-agnostic application for HD-quality medical video and image recording in clinical and OR settings. The user interface allows capture, marking, storage and sharing of files that has integration capability with patient EMR (HL7) and PACS/VNA (DICOM). The application and its browser allow access to a secure space within the client's network that facilitates remote and local file review, referrals and consultations with a HIPAA conformant logon authorization. Intended functions include medical process automation: procedural steps, population of patient demographic data, and management of active medical media from scheduling through discharge.
D-Scope Systems
6
In Commercial Distribution

  • 00860009377608 ()


  • Endoscopic video image processing unit
No Description
Synaptive Medical Inc
2.2
In Commercial Distribution

  • 00670082000627 ()
SYN-0867

  • Neurological stereotactic surgery system
No Description
Synaptive Medical Inc
2.1
In Commercial Distribution

  • 00670082000504 ()
SYN-0867

  • Neurological stereotactic surgery system
No Description
Synaptive Medical Inc
1.5
In Commercial Distribution

  • 00670082000375 ()
SYN-0027

  • Neurological stereotactic surgery system
No Description
Synaptive Medical Inc
1.4
In Commercial Distribution

  • 00670082000191 ()
SYN-0027

  • Neurological stereotactic surgery system
No Description
Synaptive Medical Inc
1.3
In Commercial Distribution

  • 00670082000078 ()
SYN-0027

  • Neurological stereotactic surgery system
Software used by the clinician to interface with the WalkAide unit. This allows data collection, analysis and parameter modification in order to correctly time the applied stimulation to the user.
INNOVATIVE NEUROTRONICS, INC.
20-0603
In Commercial Distribution

  • 00858184006130 ()


  • Gait-enhancement electrical stimulation system, external
Specialized user interface software
INTERSON CORP
x.x
In Commercial Distribution

  • 00850921007189 ()


  • General-purpose ultrasound imaging system
No Description
VIEWRAY INCORPORATED
A3i
In Commercial Distribution

  • 00850036816027 ()


  • Linear accelerator system
  • Stereotactic teletherapy radionuclide system, MRI-imaging
No Description
ORAMETRIX, INC.
7.6
In Commercial Distribution

  • 00856379007085 ()


  • CAD/CAM software
SFW KIT 9735739 STEALTH S8 STEREOTX
MEDTRONIC NAVIGATION, INC.
9735739
In Commercial Distribution

  • 00643169838987 ()


  • Neurological stereotactic surgery system
SFW KIT 9735738 STEALTH S8 CRN DBS
MEDTRONIC NAVIGATION, INC.
9735738
In Commercial Distribution

  • 00643169838970 ()


  • Neurological stereotactic surgery system
SW KIT 9735737 STEALTH S8 CRANIAL
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution

  • 00643169838963 ()


  • Neurological stereotactic surgery system
SFW KIT 9735916 S8 CRANIAL PLAN STATION
MEDTRONIC NAVIGATION, INC.
9735916
In Commercial Distribution

  • 00643169931329 ()


  • Neurological stereotactic surgery system
SFW KIT 9735921 S8 DBS STEREOTX
MEDTRONIC NAVIGATION, INC.
9735921
In Commercial Distribution

  • 00643169921917 ()


  • Neurological stereotactic surgery system
SFW 9735911 STEALTH S8 STEREOTAXY
MEDTRONIC NAVIGATION, INC.
9735911
In Commercial Distribution

  • 00643169878211 ()


  • Neurological stereotactic surgery system
SFW 9735910 STEALTH S8 DBS
MEDTRONIC NAVIGATION, INC.
9735910
In Commercial Distribution

  • 00643169878204 ()


  • Neurological stereotactic surgery system
SW APP 9735762 STEALTH S8 APP
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00643169865341 ()


  • Multi-purpose stereotactic surgery system
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF003
In Commercial Distribution

  • 00850013007417 ()
ELF003

  • Audiometric/hearing device software
The Eonis Analysis Software is intended for in vitro diagnostic use for analysis of the real time PCR data generated usingthe Eonis PCR Reagent Kit for the semi-quantitative determination of TREC (signal joint T-cell receptor excision circle)and KREC (Kappa-deleting recombination excision circle), as well as the qualitative detection of the exon 7 of SMN1gene and RPP30 (Ribonuclease P/MRP Subunit P30) gene in DNA from blood specimens dried on a filter paper as an aidin screening newborns for Severe Combined Immunodeficiency (SCID), X-linked agammaglobulinemia (XLA) and SpinalMuscular Atrophy (SMA).
Wallac Oy
5020-1000
In Commercial Distribution

  • 06438147373901 ()
5020-1000

  • Human genomic analysis interpretive software IVD
No Description
ACCUTOME, INC.
2.06.02-U
In Commercial Distribution

  • 00897826002147 ()


  • Ophthalmic ultrasound imaging system
No Description
CAScination AG
4.1
In Commercial Distribution

  • 07616962000250 ()
20016

  • Radiology picture archiving and communication system workstation
No Description
Institut Straumann AG
1
Not in Commercial Distribution

  • 07630031738820 ()
019.2033

  • Dental milling system, CAD/CAM, chairside
No Description
Institut Straumann AG
1
Not in Commercial Distribution

  • 07630031738813 ()
019.2032

  • Dental milling system, CAD/CAM, laboratory
Cranial Guidance Enable
Stryker Leibinger GmbH & Co. KG
6000-670-300
In Commercial Distribution

  • 07613327538410 ()
6000-670-300

  • Electromagnetic/optical surgical navigation device tracking system
Cranial Guidance Sales Demo
Stryker Leibinger GmbH & Co. KG
81-81042
In Commercial Distribution

  • 07613327538328 ()
81-81042

  • Electromagnetic/optical surgical navigation device tracking system
No Description
ORTHOSENSOR INC
5.6.1.138
Not in Commercial Distribution

  • 07613327581843 ()
05000-VRSE

  • Arthroplasty force sensor display unit
Impsoft data management & analysis software
IMPEDIMED LIMITED
2.2.0
In Commercial Distribution

  • B277292U400CD2 ()
  • B277292U400CD1 ()
  • B277292U400CD0 ()
292-U400CD

  • Bioelectrical body composition analyser
No Description
VERAN MEDICAL TECHNOLOGIES INC.
SFT-0010
Not in Commercial Distribution

  • 00815686021085 ()
SFT-0010

  • Virtual bronchoscopic navigation PACS software
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