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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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ViewMate™ - 05415067030733

Software Upgrade
ST. JUDE MEDICAL, INC.
H900004
In Commercial Distribution

  • 05415067030733 ()
H900004

  • General-purpose ultrasound imaging system

EnSite Precision™ - 05415067030085

Software Installation
ST. JUDE MEDICAL, INC.
H702469-SW
In Commercial Distribution

  • 05415067030085 ()
H702469-SW

  • Cardiac mapping system application software

TactiCath™ Ablation Catheter, Sensor Enabled™ - 05415067028181

Software Installation
ST. JUDE MEDICAL, INC.
H702517-T
In Commercial Distribution

  • 05415067028181 ()
H702517-T

  • Cardiac mapping system application software

TactiCath™ Ablation Catheter, Sensor Enabled™ - 05415067028174

Software Installation
ST. JUDE MEDICAL, INC.
H702517
In Commercial Distribution

  • 05415067028174 ()
H702517

  • Cardiac mapping system application software

FlexAbility™ Ablation Catheter, Sensor Enabled™ - 05415067026248

Software Installation
ST. JUDE MEDICAL, INC.
H702509
In Commercial Distribution

  • 05415067026248 ()
H702509

  • Cardiac mapping system application software

Advisor™ FL Mapping Catheter, Sensor Enabled™ - 05415067026231

Software Installation
ST. JUDE MEDICAL, INC.
H702507
In Commercial Distribution

  • 05415067026231 ()
H702507

  • Electrical-only medical device connection adaptor, reusable

MediGuide™ - 05415067014672

Software Installation
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067014672 ()
MG1000

  • Cardiac mapping system

Sunrise - 05430001896015

Sunrise software
Sunrise
1
In Commercial Distribution

  • 05430001896015 ()


  • Sleep disorder interpretive software, professional-only

VNS Therapy® Model 250 v10.0 Programming Software - 05425025750382

Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750382 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v11.0 Programming Software - 05425025750375

Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750375 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v11.0 Programming Software - 05425025750368

Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750368 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v10.0 Programming Software - 05425025750214

Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750214 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v8.1 Programming Software (X5) - 05425025750191

Programming Software
LIVANOVA USA, INC.
250 v8.1 (X5)
In Commercial Distribution

  • 05425025750191 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v8.1 Programming Software (X50) - 05425025750184

Programming Software
LIVANOVA USA, INC.
250 v8.1 (X50)
In Commercial Distribution

  • 05425025750184 ()


  • Vagus nerve electrical stimulation system programmer

QuantaFlo - 00859433006123

Software Application
SEMLER SCIENTIFIC, INC.
52-0100
In Commercial Distribution

  • 00859433006123 ()


  • Limb plethysmograph

Hearing Help Express - 00858177007236

Fitting Software
INTRICON CORPORATION
Accu-Fit
In Commercial Distribution

  • 00858177007236 ()
23115

  • Hearing aid wireless-fitting computer-aided set

Natus - 05713315008672

Acculink Software
Natus Medical Denmark ApS
8-49-88800
In Commercial Distribution

  • 05713315008672 ()
8-49-88800

  • Evoked-potential audiometer

On Call Diabetes Management Software - 00682607001118

PC Software
Acon Laboratories, Inc.
1.2.89
In Commercial Distribution

  • 00682607001118 ()


  • Glucose monitoring system IVD, home-use
  • Glucose monitoring system IVD, point-of-care

Lumipulse G ROMA - 00869164000017

Software Disk
Fujirebio Diagnostics, Inc.
CL0004
In Commercial Distribution

  • 00869164000017 ()


  • Laboratory instrument/analyser application software IVD

TrackX - 00860099000837

TrackX Software
TrackX Technology, LLC
TrackX Software
In Commercial Distribution

  • 00860099000837 ()
N/A

  • Diagnostic x-ray digital imaging system workstation application software

ICU Medical MedNet - 10887709101811

Mednet Software
ICU MEDICAL, INC.
6.32.0
In Commercial Distribution

  • 10887709101811 ()
160379203

  • Infusion pump medication-dosage application software

Mammotome - 00841911101833

Software Package
DEVICOR MEDICAL PRODUCTS, INC.
SCMSW6
In Commercial Distribution

  • 00841911101833 ()
SCMSW6

  • Mammographic stereotactic biopsy system

Mammotome - 00841911100638

Software Package
DEVICOR MEDICAL PRODUCTS, INC.
Version 6.2
In Commercial Distribution

  • 00841911100638 ()


  • Mammographic stereotactic biopsy system

ICU Medical MedNet - 10887787009139

Mednet Software
ICU MEDICAL, INC.
6.31.01
In Commercial Distribution

  • 10887787009139 ()
160379202

  • Infusion pump medication-dosage application software

ICU Medical MedNet - 10887787009115

Mednet Software
ICU MEDICAL FLEET SERVICES, LLC
6.30.01
In Commercial Distribution

  • 10887787009115 ()
160379201

  • Infusion pump medication-dosage application software

MedNet - 10887787001751

Metnet Software
HOSPIRA, INC.
6.20.01
In Commercial Distribution

  • 10887787001751 ()
160376404

  • Infusion pump medication-dosage application software

Welch Allyn, Inc. - 00732094296334

TAGconnect Software
WELCH ALLYN, INC.
901099
In Commercial Distribution

  • 00732094296334 ()
TAGECG-SWF

  • Electrocardiographic ambulatory recorder

Apollo Knee - 05056139245862

ApolloKnee Software
CORIN LTD
TKR.SS.0001
In Commercial Distribution

  • 05056139245862 ()


  • Robotic surgical arm system

JointVue jFit - 00850014885021

jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885021 ()


  • Ultrasound imaging system application software

GammaPod™ Treatment Planning System - 00850002615029

TPS Software
XCISION MEDICAL SYSTEMS, LLC
Model A
In Commercial Distribution

  • 00850002615029 ()
XMSGP030A09.07-001

  • Stereotactic system application software

GammaPod™ Treatment Control System - 00850002615012

TCS Software
XCISION MEDICAL SYSTEMS, LLC
Model A
In Commercial Distribution

  • 00850002615012 ()
XMSGP030A09.06-101

  • Stereotactic system application software

Vave - 00850001977043

Software Application
Vave Health, Inc.
VUA
Not in Commercial Distribution

  • 00850001977043 ()
VUA

  • Ultrasound imaging system application software

Vyaire - 04250892905945

SentrySuite Software
Jaeger Medical GmbH
3.30
In Commercial Distribution

  • 04250892905945 ()
V-770968

  • Pulmonary function analysis system, adult

Vyaire - 04250892905709

SentrySuite Software
Jaeger Medical GmbH
3.10
In Commercial Distribution

  • 04250892905709 ()
V-770962-13

  • Pulmonary function analysis system, adult

Vyaire - 04250892904634

SentrySuite Software
Jaeger Medical GmbH
2.15
In Commercial Distribution

  • 04250892904634 ()
V-770843-13

  • Pulmonary function analysis system, adult

Vyaire - 04250892904610

SentrySuite Software
Jaeger Medical GmbH
2.21
In Commercial Distribution

  • 04250892904610 ()
V-770846

  • Pulmonary function analysis system, adult

Vyaire - 04250892904597

JLAB Software
Jaeger Medical GmbH
5.7
In Commercial Distribution

  • 04250892904597 ()
V-770868-13

  • Pulmonary function analysis system, adult

SentrySuite - 04250892901053

SentrySuite Software
Jaeger Medical GmbH
2.21
Not in Commercial Distribution

  • 04250892901053 ()
V-770846

  • Pulmonary function analysis system, adult

Jaeger - 04250892900667

SentrySuite Software
Jaeger Medical GmbH
2.19
Not in Commercial Distribution

  • 04250892900667 ()
V-770845-13

  • Pulmonary function analysis system, adult

Jaeger - 04250892900186

SentrySuite Software
Jaeger Medical GmbH
2.17
Not in Commercial Distribution

  • 04250892900186 ()
V-770844-13

  • Pulmonary function analysis system, adult

Jaeger - 04250892900162

SentrySuite Software
Jaeger Medical GmbH
2.13
Not in Commercial Distribution

  • 04250892900162 ()
V-770842-13

  • Pulmonary function analysis system, adult

Vyaire - 04250892905891

SentrySuite Software
Jaeger Medical GmbH
3.20
In Commercial Distribution

  • 04250892905891 ()
V-770965

  • Cardiopulmonary stress exercise monitoring system

Vyaire - 04250892904627

SentrySuite Software
Jaeger Medical GmbH
2.19
In Commercial Distribution

  • 04250892904627 ()
V-770845-13

  • Pulmonary function analysis system, adult

Vyaire - 04250892904603

SentrySuite Software
Jaeger Medical GmbH
3.0
In Commercial Distribution

  • 04250892904603 ()
V-770847

  • Pulmonary function analysis system, adult

Vyaire - 04250892904580

JLAB Software
Jaeger Medical GmbH
5.7
In Commercial Distribution

  • 04250892904580 ()
V-770808

  • Pulmonary function analysis system, adult

Jaeger - 04250892900179

SentrySuite Software
Jaeger Medical GmbH
2.15
Not in Commercial Distribution

  • 04250892900179 ()
V-770843-13

  • Pulmonary function analysis system, adult

Jaeger - 04250892900100

JLAB Software
Jaeger Medical GmbH
5.7
Not in Commercial Distribution

  • 04250892900100 ()
V-770808

  • Pulmonary function analysis system, adult

Gendex VixWin™ imaging software - EKAV101037680

Imaging software
GENDEX CORP.
3
In Commercial Distribution

  • EKAV101037680 ()
VIXWINPL

  • Radiology information system application software

MAESTRO 9.0 - 09008737370367

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
37036
In Commercial Distribution

  • 09008737370367 ()


  • Audiometric/hearing device software

MAESTRO 7.0 Download - 09008737368579

Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
36857
Not in Commercial Distribution

  • 09008737368579 ()


  • Audiometric/hearing device software
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