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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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NA - EPTWS0700070

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
WedgeAngle Software
In Commercial Distribution

  • EPTWS0700070 ()
S070007

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NOMEX - EPTWS0300080

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
NOMEX software
In Commercial Distribution

  • EPTWS0300080 ()
S030008

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0200120

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
DiaCanSet software
In Commercial Distribution

  • EPTWS0200120 ()
S020012

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0200110

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
DiaCom software
In Commercial Distribution

  • EPTWS0200110 ()
S020008

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0200080

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
DiaCom software
In Commercial Distribution

  • EPTWS0200080 ()
S020008

  • Multi-modality therapeutic radiation phantom, anthropomorphic

BIS Module - 00884838051515

IntelliVue Bispectral Index (BIS) Module M1034B for use with IntelliVue Patient Monitors MP40-MP90 and MX500-MX800. Bispectral Index (BIS) monitoring helps to monitor the level of consciousness of a patient under general anesthesia or sedation in the OR and ICU.
Philips Medizin Systeme Böblingen GmbH
IntelliVue BIS Module
In Commercial Distribution

  • 00884838051515 ()
866421

  • Patient monitoring system module, interfacing

BIS - 10884521808317

BIS (TM) Advance Monitor
Covidien LP
PMB4000ACBL
In Commercial Distribution

  • 10884521808317 ()


  • Analytical scalp lead

BIS - 10884521808300

BIS (TM) Advance Docking Station
Covidien LP
PMB4000DOC
In Commercial Distribution

  • 10884521808300 ()


  • Anaesthesia depth monitor

BIS - 10884521808270

BIS (TM) Advance Monitor
Covidien LP
PMB4000
In Commercial Distribution

  • 10884521808270 ()


  • Anaesthesia depth monitor

UltraviewSL - 10841522108754

OPTION, BISX BASE MODULE, REFURB
SPACELABS HEALTHCARE (WASHINGTON), INC
91482
In Commercial Distribution

  • 10841522108754 ()
N/A

  • Patient monitoring system module, electroencephalographic

UltraviewSL - 10841522100253

MODULE BISX, 91482
SPACELABS HEALTHCARE (WASHINGTON), INC
Module: BISx
In Commercial Distribution

  • 10841522100253 ()
91482

  • Patient monitoring system module, electroencephalographic

Rapid - B761R51020

Rapid System Update
Ischemaview, Inc.
5.102
In Commercial Distribution

  • B761R51020 ()


  • Radiological PACS software

Narcotrend Patient lead - 04260497025016

2-channel (4 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)
MT MonitorTechnik GmbH & Co. KG
PKM4
In Commercial Distribution

  • 04260497025016 ()


  • Electroencephalographic monitoring system

Narcotrend Patient lead - 04260497025009

1-channel (3 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)
MT MonitorTechnik GmbH & Co. KG
PKM1
In Commercial Distribution

  • 04260497025009 ()


  • Electroencephalographic monitoring system

Narcotrend-Compact M - 04260497021063

No Description
MT MonitorTechnik GmbH & Co. KG
T5
In Commercial Distribution

  • 04260497021063 ()
  • 04260497021070 ()


  • Electroencephalographic monitoring system

cortiQ PRO - EBCI80600

cortiQ PRO is a system that uses g.HIamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the high-gamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements.
g.tec medical engineering GmbH
TD 1.x
In Commercial Distribution

  • EBCI80600 ()


  • Electroencephalographic spectrum analyser

Rapid - B761R51011

Rapid System Update
Ischemaview, Inc.
5.101
In Commercial Distribution

  • B761R51011 ()


  • Radiological PACS software

Samsung ECG Monitor App 1.3 (with High HR_Android OS) - 08806094948240

The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
Samsung Electronics Co., Ltd.
1.3
In Commercial Distribution

  • 08806094948240 ()


  • Self-care monitoring/reporting software

Samsung ECG Monitor App 1.3 (with High HR_Wear OS) - 08806094948233

The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
Samsung Electronics Co., Ltd.
1.3
In Commercial Distribution

  • 08806094948233 ()


  • Self-care monitoring/reporting software

Samsung ECG Monitor App with Irregular Heart Rhythm Notification - 08806094940763

The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094940763 ()


  • Self-care monitoring/reporting software

Samsung ECG Monitor App with Irregular Heart Rhythm Notification - 08806094940756

The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094940756 ()


  • Self-care monitoring/reporting software

Axon - 09413000078510

Neurofeedback Software Application for Android
EXSURGO LIMITED
Android
In Commercial Distribution

  • 09413000078510 ()
100321

  • Psychophysiological biofeedback system

Cochlear - 09321502046503

Osia™ Fitting Software 2
COCHLEAR LIMITED
P1593077
In Commercial Distribution

  • 09321502046503 ()
P1593077

  • Audiometric/hearing device software

Cochlear - 09321502044905

Osia™ Fitting Software 2
COCHLEAR LIMITED
P1348428
In Commercial Distribution

  • 09321502044905 ()
P1348428

  • Audiometric/hearing device software

Cochlear - 09321502044899

Osia™ Fitting Software 2
COCHLEAR LIMITED
P1341442
In Commercial Distribution

  • 09321502044899 ()
P1341442

  • Audiometric/hearing device software

Compumedics Grael - 09342451001313

Grael PSG System, no software
COMPUMEDICS LIMITED
Grael PSG
In Commercial Distribution

  • 09342451001313 ()
9028-0009-01

  • Polysomnograph

Compumedics Grael - 09342451001290

Grael LT System, no software
COMPUMEDICS LIMITED
Grael LT
In Commercial Distribution

  • 09342451001290 ()
9028-0008-01

  • Electroencephalograph

Compumedics Grael - 09342451001276

Grael v2 System, no software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001276 ()
9028-0001-02

  • Electroencephalograph
  • Polysomnograph

Kosmos OTS iOS Software Package - 09353278000717

Kosmos OTS iOS Software Package
ECHONOUS, INC.
P007639
In Commercial Distribution

  • 09353278000717 ()


  • Ultrasound imaging system application software

Kosmos OTS - 09353278000588

Ultrasound imaging system application software
ECHONOUS, INC.
P006576
In Commercial Distribution

  • 09353278000588 ()


  • Ultrasound imaging system application software

VistaScan™ - 00850017464001

VistaScan™ Software 1.x.x
EMAGINE SOLUTIONS TECHNOLOGY LLC
1.x.x
In Commercial Distribution

  • 00850017464001 ()


  • Ultrasound imaging system application software

Vave - 00850001977104

Software Application 3X version onwards
Vave Health, Inc.
VA-0303
In Commercial Distribution

  • 00850001977104 ()


  • Hand-held ultrasound imaging system, body-surface

Leica Biosystems Ariol Review Software - 00849832003830

Leica Biosystems Ariol Review Software
Leica Biosystems Richmond, Inc.
23ASWREV001
In Commercial Distribution

  • 00849832003830 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

StealthStation® iNav w/ AxiEM™ TechNology - 00613994231383

SOFTWARE 9733260 AXIEM CRANIAL INAV
MEDTRONIC NAVIGATION, INC.
9733260
In Commercial Distribution

  • 00613994231383 ()


  • Multi-purpose stereotactic surgery system

EX-M1 - 04547410448214

A hardware for installing software.
FUJIFILM CORPORATION
DR-ID1200 GPU EX-M1 MDR E
In Commercial Distribution

  • 04547410448214 ()


  • Diagnostic x-ray digital imaging conversion system

ORTHOMAP - 04546540717450

ORTHOMAP¿ EXPRESS KNEE 2.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6003-672-000
In Commercial Distribution

  • 04546540717450 ()
6003-672-000

  • Robotic surgical navigation system application software

ORTHOMAP - 04546540717443

ORTHOMAP¿ PRECISION KNEE 5.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6003-655-000
In Commercial Distribution

  • 04546540717443 ()
6003-655-000

  • Robotic surgical navigation system application software

AVEA - 10190752159075

KIT, AVEA UPGRADE GDE & SOFTWARE
VYAIRE MEDICAL, INC.
12284-PMN
Not in Commercial Distribution

  • 10190752159075 ()
12284-PMN

  • Patient monitoring system module, pulse oximetry
  • Ventilator application software

EnSite™ - 05415067001856

Software Upgrade Kit v.3.1
ST. JUDE MEDICAL, INC.
H700185
In Commercial Distribution

  • 05415067001856 ()
H700185

  • Cardiac mapping system application software

EP-WorkMate™ - 05415067000866

Software Upgrade Kit v.4.3.2
ST. JUDE MEDICAL, INC.
H700086
In Commercial Distribution

  • 05415067000866 ()
H700086

  • Cardiac catheterization monitoring system
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