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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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VITEK®2 software 9.01 update, advanced software to run your VITEK®2 system, second version
BIOMERIEUX , INC.
9.01.1
In Commercial Distribution

  • 03573026619060 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
No Description
Cochlear Bone Anchored Solutions AB
V 7.0
In Commercial Distribution

  • 09321502075510 ()
P2121898

  • Hearing aid wireless-fitting computer-aided set
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. After the patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital’s PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Centerline Biomedical, Inc.
SW-1
In Commercial Distribution

  • 00843152104000 ()
SW-1

  • Electromagnetic surgical navigation device tracking system
Inductive Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF002
Not in Commercial Distribution

  • 00850013007295 ()
ELF002

  • Audiometric/hearing device software
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
480 Channel
In Commercial Distribution

  • 00850011306888 ()
36-0301-0044

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
416 Channel
In Commercial Distribution

  • 00850011306864 ()
36-0301-0042

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
352 Channel
In Commercial Distribution

  • 00850011306840 ()
36-0301-0040

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
320 Channel
In Commercial Distribution

  • 00850011306833 ()
36-0301-0039

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
288 Channel
In Commercial Distribution

  • 00850011306826 ()
36-0301-0038

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
256 Channel
In Commercial Distribution

  • 00850011306819 ()
36-0301-0037

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
224 Channel
In Commercial Distribution

  • 00850011306802 ()
36-0301-0036

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
192 Channel
In Commercial Distribution

  • 00850011306796 ()
36-0301-0035

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
160 Channel
In Commercial Distribution

  • 00850011306789 ()
36-0301-0034

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
128 Channel
In Commercial Distribution

  • 00850011306772 ()
36-0301-0033

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
96 Channel
In Commercial Distribution

  • 00850011306765 ()
36-0301-0032

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
64 channel
In Commercial Distribution

  • 00850011306758 ()
36-0301-0031

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
512 Channel
In Commercial Distribution

  • 00850011306895 ()
36-0301-0045

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
448 Channel
In Commercial Distribution

  • 00850011306871 ()
36-0301-0043

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
384 Channel
In Commercial Distribution

  • 00850011306857 ()
36-0301-0041

  • Electroencephalographic monitoring system
The ATLAS Neurophysiology System is intended to be used for temporary (<30 days) recording and monitoring of brain electrical activity. The Pegasus software is a component of the ATLAS Neurophysiology System.
NEURALYNX, INC.
32 channel
In Commercial Distribution

  • 00850011306741 ()
36-0301-0030

  • Electroencephalographic monitoring system
No Description
LIFE TECHNOLOGIES CORPORATION
A54762
In Commercial Distribution

  • 10190302018135 ()


  • Laboratory instrument/analyser application software IVD
No Description
OTODYNAMICS LIMITED
OTOLINK
In Commercial Distribution

  • 05060396170591 ()


  • Evoked-potential audiometer
  • Otoacoustic emission system, battery-powered
E-LINK is a computerized modular system bringing both evaluation and exercise together in an exciting format with an extensive scope of clinical applications for the upper and lower extremities. E-LINK is available in English, Chinese, German and Spanish.
BIOMETRICS LIMITED
16xx-xxx-xxxx
In Commercial Distribution

  • 05060481690454 ()


  • Biomechanical function analysis/rehabilitation software
Care Orchestrator Essence, Clinical data collection management information system application software
Respironics, Inc.
3.3
In Commercial Distribution

  • 00606959060449 ()
1135709

  • Medical equipment clinical data interfacing software
Care Orchestrator Essence, Clinical data collection management information system application software
Respironics, Inc.
3.2
In Commercial Distribution

  • 00606959059689 ()
1135709

  • Medical equipment clinical data interfacing software
Care Orchestrator Essence, Clinical data collection management information system application software
Respironics, Inc.
3.1
In Commercial Distribution

  • 00606959059085 ()
1135709

  • Medical equipment clinical data interfacing software
A comprehensive analysis suite for magnetoencephalographic and electroencephalographic data acquired with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUX™ neo.
Megin Oy
SW23380N
In Commercial Distribution

  • 06430056480022 ()


  • Electroencephalograph
No Description
Philips Ultrasound LLC
989605496481
In Commercial Distribution

  • 00884838091672 ()


  • Radiological PACS software
No Description
Philips Ultrasound LLC
989605492681
In Commercial Distribution

  • 00884838090736 ()


  • Radiological PACS software
No Description
Philips Ultrasound LLC
989605465051
In Commercial Distribution

  • 00884838084322 ()


  • Radiological PACS software
Guideline 4000™ Resident Expert Software Module, 1x
FHC, INC.
C0258-00818
In Commercial Distribution

  • 00873263008188 ()
C0258

  • Neurophysiologic monitoring system
Guideline 4000™ Resident Expert Software Module, 1x
FHC, INC.
C0258-00808
Not in Commercial Distribution

  • 00873263008089 ()
C0258

  • Neurological stereotactic surgery system
VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console)
ORTHO KINEMATICS, INC.
3
In Commercial Distribution

  • 00868579000230 ()


  • Radiological PACS software
No Description
ZOLL MANUFACTURING CORPORATION
Version 1.0
In Commercial Distribution

  • 00855778005333 ()


  • Electrocardiograph, professional, multichannel
The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow monitoring and recording of electrocardiograph (ECG) rhythm strips and related information for patients undergoing an exercise therapy program. Patients are monitored by medical telemetry exercise monitoring equipment. This feature allows patients to comply with exercise prescriptions while exercising at a medical/rehabilitation facility near their home, or by returning to the primary medical facility to participate in an in-house cardiopulmonary rehabilitation program. VersaCare includes a Program Management module that prints a variety of reports.
SCOTTCARE CORPORATION, THE
TeleRehab Software File Manager
In Commercial Distribution

  • 00856298006244 ()
101601

  • Electrocardiography telemetric monitoring system
User interface in the patient's room
Vital Connect, Inc.
6100-03
In Commercial Distribution

  • 00850490007382 ()
6100-03

  • Electrocardiography telemetric monitoring system
User interface in the patient's room
Vital Connect, Inc.
6100-01
In Commercial Distribution

  • 00850490007160 ()
6100-01

  • Electrocardiography telemetric monitoring system
No Description
INTERSON CORP
x.x
In Commercial Distribution

  • 00850921007202 ()


  • General-purpose ultrasound imaging system
No Description
MEDSPIRA, LLC
RMD-002-001
In Commercial Distribution

  • 00851607003211 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-001-003
In Commercial Distribution

  • 00851607003204 ()


  • Manometric gastrointestinal motility analysis system
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