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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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ZIO XT Patch - 00869770000203

ZIO XT ECG Monitoring Service
IRHYTHM TECHNOLOGIES, INC.
N100A102X
In Commercial Distribution

  • 00869770000203 ()


  • Electrocardiographic ambulatory recorder

VMA Motion Normalizer - 00868579000247

VMA Motion Normalizer (Console, Table, and Upright assemblies)
ORTHO KINEMATICS, INC.
3
In Commercial Distribution

  • 00868579000247 ()


  • Diagnostic x-ray digital imaging system workstation

VMA - 00868579000209

No Description
ORTHO KINEMATICS, INC.
2
In Commercial Distribution

  • 00868579000209 ()


  • Diagnostic x-ray digital imaging system workstation

100mm x 22m ECG Printer Paper (2/roll) - 00681490597722

PAPER ROLLS, 100MM WIDE,ECG
PHYSIO-CONTROL, INC.
11240
Not in Commercial Distribution

  • 00681490597722 ()
11240-000016

  • Patient monitoring system module, printing

50mm x 22m ECG Printer Paper (3/roll) - 00681490595896

PAPER-ELECTROCARDIOGRAM,RECORDING
PHYSIO-CONTROL, INC.
11240
In Commercial Distribution

  • 00681490595896 ()
11240-000013

  • Patient monitoring system module, printing

Q Patch Downloader - 05903021560162

Q Patch Downloader (PC application) – The intended use of the Q Patch Downloader application is to download the data from completed Q Patch session and upload files containing ECG data to the predefine storage space.
MEDICALGORITHMICS S A
9.48
In Commercial Distribution

  • 05903021560162 ()


  • Electrocardiographic ambulatory recorder

Q Patch Mobile Application - 05903021560155

Q Patch Mobile Application (Mobile application) – The Q Patch Mobile Application is intended to be used for interacting with the Q Patch recorder for transmission patient data to set up ECG recording session and displaying the Q Patch’s status. The application is obligatory for healthcare professionals and optional for patients
MEDICALGORITHMICS S A
1.0
In Commercial Distribution

  • 05903021560155 ()


  • Electrocardiographic ambulatory recorder

Q Patch - 05903021560124

The Q Patch is a single channel ECG recorder. The device is intended to be placed on the sternum (in the middle of the chest). The Q Patch ECG recorder snaps onto the two off-the-shelf electrodes (Solid gel, Ag/AgCl) and records patient’s ECG for up to 15 days powered from single disposable, non-rechargeable battery. The Q Patch Mobile Application is used to initiate recording session, for checking Q Patch status and to finish/stop the session if needed. When the recording is finished, the ECG data stored in Q Patch’s memory can be downloaded through a USB port using the Q Patch Downloader (PC application).
MEDICALGORITHMICS S A
P5HP-AA-ADS
In Commercial Distribution

  • 05903021560124 ()


  • Electrocardiographic ambulatory recorder

ORLocate - 00724995243692

Medical Grade Tablet with 11.6 inch screen is used with the ORLocate Sponge Solution System.
STERIS CORPORATION
ORLocate Tablet
In Commercial Distribution

OX216

  • Electronic surgical sponge-counter

DigiTrak XT - 00884838000476

DigiTrak XT Holter Recorder
Philips Medical Systems Hsg
DigiTrak XT Holter Recorder
In Commercial Distribution

  • 00884838000476 ()
860322

  • Electrocardiographic ambulatory recorder

Holter Software - 00884838000469

No Description
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution

  • 00884838000469 ()
860292

  • Electrocardiographic ambulatory recorder

SOLAR Compact - 08720648846052

SOLAR Compact
Laborie Medical Technologies Corp.
G4-1
In Commercial Distribution

  • 08720648846052 ()


  • Manometric gastrointestinal motility analysis system

Solar GI air-charged 4P, Compact Pole system - 08720648846007

Solar GI air-charged 4P, Compact Pole system, 115V
Medical Measurement Systems B.V.
G3-7 Air
In Commercial Distribution

  • 08720648846007 ()


  • Manometric gastrointestinal motility analysis system

DemarkQ - 08720299044227

The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Light Tree Ventures Europe B.V.
P19-0007
In Commercial Distribution

  • 08720299044227 ()


  • Red/blue light phototherapy unit

Solar GI Trolley - 08717775957003

Solar GI Trolley
Medical Measurement Systems B.V.
GI trolley white
In Commercial Distribution

  • 08717775957003 ()
GI trolley white

  • Manometric gastrointestinal motility analysis system

Varex Imaging - 08718755000986

The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
17883-10
In Commercial Distribution

  • 08718755000986 ()


  • Multichannel radiation survey meter

Varex Imaging - 08718755000979

The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
14097-10
In Commercial Distribution

  • 08718755000979 ()


  • Multichannel radiation survey meter

Varex Imaging - 08718755000962

The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
14181-10
In Commercial Distribution

  • 08718755000962 ()


  • Multichannel radiation survey meter

Varex Imaging - 08718755000955

The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
14315-10-01
In Commercial Distribution

  • 08718755000955 ()


  • Multichannel radiation survey meter

Varex Imaging - 08718755000948

The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
14315-10
In Commercial Distribution

  • 08718755000948 ()


  • Multichannel radiation survey meter

Varex Imaging - 08718755000931

The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series
Varex Imaging Nederland B.V.
13034-10
In Commercial Distribution

  • 08718755000931 ()


  • Multichannel radiation survey meter

Varex Imaging - 08718755000924

The AmpMC is intended to convert an electrical current form a Solid State Measuring Chamber to a voltage ramp or voltage level that can be interpreted by the Automatic Exposure Control interface of a High Voltage Generator. This device is one out of the AmpMC-series.
Varex Imaging Nederland B.V.
12860-10
In Commercial Distribution

  • 08718755000924 ()


  • Multichannel radiation survey meter

syngo X Workplace - 04056869010113

No Description
Siemens Healthcare GmbH
10502522
In Commercial Distribution

  • 04056869010113 ()


  • Diagnostic x-ray digital imaging system workstation

syngo X Workplace - 04056869010120

No Description
Siemens Healthcare GmbH
10281299
In Commercial Distribution

  • 04056869010120 ()


  • Diagnostic x-ray digital imaging system workstation

Midmark Digital ECG - 00841709121319

Midmark Digital ECG from Midmark is an easy-to-use, digital, 12-lead resting ECG solution that helps you quickly administer testing and access patient test results you need to make informed cardiac assessments and provide more efficient patient care. Kit includes Midmark Digital ECG device - USB version, 10-Lead Patient Cable, 10-Pack Clear ECG Clips, and 100-Pack Disposable ECG Electrodes, Device silicon cover.
MIDMARK CORPORATION
4-000-0080
In Commercial Distribution

  • 00841709121319 ()
4-000-0080

  • Electrocardiographic ambulatory recorder

coDiagnostiX - D835CODX1

Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation

coDiagnostiX - D835CDX1

Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation

AXIR-CX - 08800099500076

Radiological Image Processing System
Radisen Co., Ltd.
AXIR-CX
In Commercial Distribution

  • 08800099500076 ()
AXIR-CX

  • Diagnostic x-ray digital imaging system workstation

Nuubo System - 08437011759078

NuuboREC Box USA. Ambulatory ECG monitoring device (Holter) up to 30 days.
SMART SOLUTIONS TECHNOLOGIES SL
2140
In Commercial Distribution

  • 08437011759078 ()
2140

  • Electrocardiographic ambulatory recorder

Holter Prep Kit - 10812345026020

Holter prep kit with AAA battery cleared with H3+ Holter recorder
MORTARA INSTRUMENT, INC.
XKTHOLT5LA
Not in Commercial Distribution

  • 30812345026024 ()
  • 20812345026027 ()
  • 10812345026020 ()


  • Electrocardiographic ambulatory recorder

PULSE - 00195377058539

PULSE LessRay Tablet, Labeled
Nuvasive, Inc.
1833071
In Commercial Distribution

  • 00195377058539 ()


  • Diagnostic x-ray digital imaging system workstation

PULSE - 00195377058508

PULSE LessRay Battery Pk, Tablet Labeled
Nuvasive, Inc.
1802417
In Commercial Distribution

  • 00195377058508 ()


  • Diagnostic x-ray digital imaging system workstation

PULSE - 00195377057037

PULSE LessRay Tablet Charging Station
Nuvasive, Inc.
1801815
In Commercial Distribution

  • 00195377057037 ()


  • Diagnostic x-ray digital imaging system workstation

PULSE - 00195377057020

PULSE LessRay GE C-arm Mount
Nuvasive, Inc.
1801814
In Commercial Distribution

  • 00195377057020 ()


  • Diagnostic x-ray digital imaging system workstation

ManoScan - 10884521853317

Manoscan Cart
Given Imaging, Inc.
FGS-8038
In Commercial Distribution

  • 10884521853317 ()

  • Power Force,120/240,Volt;Frequency,50/60,HZ,Current,5.2/2.6,AMP;


  • Manometric gastrointestinal motility analysis system

Endoflip - 10884521826830

300 Reader
Covidien LP
EF-304
In Commercial Distribution

  • 10884521826830 ()


  • Manometric gastrointestinal motility analysis system

Endoflip - 10884521826823

300 Cart
Covidien LP
EF-303
In Commercial Distribution

  • 10884521826823 ()


  • Manometric gastrointestinal motility analysis system

Endoflip - 10884521826816

300 Display System With Reader
Covidien LP
EF-302
In Commercial Distribution

  • 10884521826816 ()


  • Manometric gastrointestinal motility analysis system

Endoflip - 10884521826809

300 Pump System With Pre-Use Tube
Covidien LP
EF-301
In Commercial Distribution

  • 10884521826809 ()


  • Manometric gastrointestinal motility analysis system

Endoflip - 10884521833869

Refurbished 300 Pump System With Pre-Use Tube
Covidien LP
EF-301-RFB
In Commercial Distribution

  • 10884521833869 ()


  • Manometric gastrointestinal motility analysis system
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