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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CardioSTAT ECG Recorder 7D Test.
Icentia Inc.
10-006
In Commercial Distribution

  • 17540279200072 ()
  • 27540279200079 ()


  • Electrocardiographic ambulatory recorder
ECG Analysis and Reporting Tool.
Icentia Inc.
10-501
In Commercial Distribution

  • 17540279105018 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
45mm Curved Tip Stapler
INTUITIVE SURGICAL, INC.
436504
In Commercial Distribution

  • 10886874123659 ()
  • 00886874123652 ()

  • Length: 45 Millimeter
  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use
45mm Straight Tip Stapler
INTUITIVE SURGICAL, INC.
436502
In Commercial Distribution

  • 10886874123642 ()
  • 00886874123645 ()

  • Length: 45 Millimeter
  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use
8mm Stapler
INTUITIVE SURGICAL, INC.
48230M
In Commercial Distribution

  • 10886874121938 ()
  • 00886874121931 ()

  • Depth: 30 Millimeter


  • Surgical staple loading unit, non-cutting
8mm Stapler
INTUITIVE SURGICAL, INC.
48230W
In Commercial Distribution

  • 10886874121921 ()
  • 00886874121924 ()

  • Depth: 30 Millimeter


  • Surgical staple loading unit, non-cutting
8mm Stapler
INTUITIVE SURGICAL, INC.
48230B
In Commercial Distribution

  • 10886874121914 ()
  • 00886874121917 ()

  • Depth: 30 Millimeter


  • Surgical staple loading unit, non-cutting
SureForm 45 Curved-Tip
INTUITIVE SURGICAL, INC.
480545
In Commercial Distribution

  • 10886874117597 ()
  • 00886874117590 ()

  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use
SureForm 45
INTUITIVE SURGICAL, INC.
480445
In Commercial Distribution

  • 10886874117580 ()
  • 00886874117583 ()

  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use
SUREFORM 45 RELOAD WHITE
INTUITIVE SURGICAL, INC.
48345W
In Commercial Distribution

  • 10886874117122 ()
  • 00886874117125 ()

  • Depth: 2.5 Millimeter


  • Surgical staple loading unit, non-cutting
SUREFORM 45 RELOAD BLACK
INTUITIVE SURGICAL, INC.
48345T
In Commercial Distribution

  • 10886874117115 ()
  • 00886874117118 ()

  • Depth: 4.6 Millimeter


  • Surgical staple loading unit, non-cutting
SUREFORM 45 RELOAD GRAY
INTUITIVE SURGICAL, INC.
48345M
In Commercial Distribution

  • 10886874117108 ()
  • 00886874117101 ()

  • Depth: 2 Millimeter


  • Surgical staple loading unit, non-cutting
SUREFORM 45 RELOAD GREEN
INTUITIVE SURGICAL, INC.
48345G
In Commercial Distribution

  • 10886874117092 ()
  • 00886874117095 ()

  • Depth: 4.3 Millimeter


  • Surgical staple loading unit, non-cutting
SUREFORM 45 RELOAD BLUE
INTUITIVE SURGICAL, INC.
48345B
In Commercial Distribution

  • 10886874117085 ()
  • 00886874117088 ()

  • Depth: 3.5 Millimeter


  • Surgical staple loading unit, non-cutting
8mm Stapler
INTUITIVE SURGICAL, INC.
488530
In Commercial Distribution

  • 10886874121723 ()
  • 00886874121726 ()

  • Outer Diameter: 8 Millimeter
  • Length: 30 Millimeter


  • Robotic surgical cutting stapler, reusable
RN Screw for CARES® Abutment, ZrO2 , and instructions for use
Institut Straumann AG
Screws
In Commercial Distribution

  • 07630031728913 ()
048.788

  • Dental prosthesis/implant abutment screw
Custom Abutment Zirconia, for Straumann RN, incl. TAN screw
Institut Straumann AG
Final Abutments
In Commercial Distribution

  • 07630031717757 ()
040.688

  • Dental implant suprastructure, permanent, preformed
Capital equipment to support the Leaf sensor patient montitoring system
SMITH & NEPHEW MEDICAL LIMITED
66802119
In Commercial Distribution

  • 05000223499907 ()
66802119

  • Wireless patient monitor/sensor reporting software, professional-only
Capital equipment to support the Leaf sensor patient montitoring system
SMITH & NEPHEW MEDICAL LIMITED
66802118
In Commercial Distribution

  • 05000223499891 ()
66802118

  • Wireless patient monitor/sensor reporting software, professional-only
A reusable, wireless, Bluetooth device that sends patient body orientation and movement information to the Bedside Mobility Monitor (BMM) that is housed within the Atlas Wearable Patch.
Atlas Lift Tech, Inc.
Rev A
In Commercial Distribution

  • 00860008806024 ()


  • Wireless patient monitor/sensor reporting software, professional-only
No Description
Atlas Lift Tech, Inc.
SE
Not in Commercial Distribution

  • 11968525122705 ()


  • Wireless patient monitor/sensor reporting software, professional-only
Holter Web Portal
Lifesignals, Inc.
UA2251-C
In Commercial Distribution

  • B353UA2251C1 ()


  • Wireless patient monitor/sensor reporting software, professional-only
Portrait Central Viewer Application Installer v1.1.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVAXB
In Commercial Distribution

  • 00195278656681 ()
5863721-11

  • Wireless patient monitor/sensor reporting software, professional-only
PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVA01
In Commercial Distribution

  • 00195278330413 ()
5863721

  • Wireless patient monitor/sensor reporting software, professional-only
Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler, Openlab software
BIOCHROM LIMITED
80-6000-53EZ
In Commercial Distribution

  • 05056336800239 ()


  • Amino acid analyser IVD
Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.
ERESEARCHTECHNOLOGY, INC.
APV2C
In Commercial Distribution

  • 00850023837035 ()


  • Kinesiology ambulatory recorder
AcrySof IQ ReSTOR Multifocal Toric IOL +2.5 D IOL Calculator
Alcon Laboratories, Inc.
Version 1
In Commercial Distribution

  • 00380659909481 ()


  • Intraocular lens calculation software
Alcon Online Barrett Toric IOL Calculator
Alcon Laboratories, Inc.
Version 2
In Commercial Distribution

  • 00380659909498 ()


  • Intraocular lens calculation software
AcrySof IQ ReSTOR Multifocal Toric IOL +3.0 D IOL Calculator
Alcon Laboratories, Inc.
Version 1.0
In Commercial Distribution

  • 00380659909474 ()


  • Intraocular lens calculation software
AcrySof® IQ Toric IOL Calculator
Alcon Laboratories, Inc.
Version 3
In Commercial Distribution

  • 00380659909467 ()


  • Intraocular lens calculation software
No Description
Carl Zeiss Meditec AG
6914
In Commercial Distribution

  • 04049539069146 ()


  • Ophthalmic surgical microscope data overlay unit
No Description
Brainlab AG
17700
In Commercial Distribution

  • 04056481142520 ()


  • Robotic surgical navigation system
  • Electromagnetic/optical surgical navigation device tracking system
PRESSURE CONTROLLER KIT
Edwards Lifesciences LLC
PC2K
In Commercial Distribution

  • 00690103193473 ()

  • Weight: 0.35 kg (0.77 lbs), Height: 97mm, Width: 54mm, Depth: 35mm, Cable Length: 3.5m
PC2K

  • Patient monitoring system module, blood pressure, noninvasive
  • Patient positioning sensor
  • General-purpose multi-parameter bedside monitor
HEART REFERENCE SENSOR
Edwards Lifesciences LLC
EVHRS
In Commercial Distribution

  • 00690103193374 ()

  • Weight: 36 Gram, Cable Length: 48 Inch
EVHRS

  • Patient positioning sensor
DVD-RW DRIVE, EXTERNAL USB
PENTAX OF AMERICA, INC.
1111-1977
In Commercial Distribution

  • 04961333241842 ()


  • DVD recorder
9250-ST Telesis® ST Software for Speech Therapy MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250-ST
In Commercial Distribution

  • 00852423006431 ()
9250-ST

  • Biofeedback system application software
Synergy® 3-Dimensional Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9225
In Commercial Distribution

  • 00852423006103 ()
9225

  • Biofeedback system application software
Primus® Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9275
In Commercial Distribution

  • 00852423006097 ()
9275

  • Biofeedback system application software
Telesis® Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250
In Commercial Distribution

  • 00852423006080 ()
9250

  • Biofeedback system application software
Biofeedback device with software
QX WORLD LTD
NA
In Commercial Distribution

  • 05999860882015 ()


  • Biofeedback system application software
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-050177-00
In Commercial Distribution

  • 06944904098715 ()


  • DVD recorder
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Z319-10
In Commercial Distribution

  • 06944904090733 ()


  • DVD recorder
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-011007-00
In Commercial Distribution

  • 06944904033419 ()


  • DVD recorder
No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00861410000246 ()
NA4

  • Biofeedback system application software
No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00861410000208 ()
ND3

  • Biofeedback system application software
NKPW Psychophysiological biofeedback system A computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer. HJLM Biofeedback system application software An application software program designed for use in, or together with, a biofeedback system, so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.
Ochs Labs LLC
LW3
In Commercial Distribution

  • G253LW30 ()


  • Biofeedback system application software
The NeXus software is intended to provide (near) real-time biofeedback and neurofeedback in the form of information, visual and auditory signals, corresponding to the state of one or more physiological parameters, so that a patient can learn voluntary control of these parameters. The software shall be used on a personal computer (in a medical office environment) in combination with compatible signal acquisition devices and sensor accessories to perform its intended use. The software is designed for medical use, not restricted to a specific medical indication. It is intended to be used within a medical office environment by, or under supervision of, a health professional (novice user, technical knowledge, normal eyesight, possibly achieved with the aid of glasses). The software is not intended for use in a life support application nor is it intended for diagnostic purposes.
Mind Media Europe B.V.
1.0.204.6
In Commercial Distribution

  • 08719481550332 ()


  • Biofeedback system application software
Neurofeedback Software
EEG SOFTWARE LLC
4
In Commercial Distribution

  • B258EEGER4 ()


  • Biofeedback system application software
No Description
Thought Technology Ltd.
SA7900AR
In Commercial Distribution

  • 07540191000647 ()


  • Biofeedback system application software
MEDIA DVD-R PANASONIC LM-RF120U
Smith & Nephew, Inc.
7210534
In Commercial Distribution

  • 00885554012354 ()
7210534

  • DVD recorder
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