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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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Mediblu - B632MDB01042

HA12P
MEDIBLU MEDICAL LLC
HA12P
In Commercial Distribution

  • B632MDB01042 ()
MDB01042

  • Electrocardiographic ambulatory recorder

Mediblu - B632MDB01024

No Description
MEDIBLU MEDICAL LLC
HP50P
In Commercial Distribution

  • B632MDB01024 ()
MDB01024

  • Arrythmia-detection blood pressure ambulatory recorder

Mediblu - B632MDB01023

No Description
MEDIBLU MEDICAL LLC
HA3P
In Commercial Distribution

  • B632MDB01023 ()
MDB01023

  • Electrocardiographic ambulatory recorder

Smart ECG - 08031527017334

MicroPort CRM Smart ECG
MICROPORT CRM SRL
K379
In Commercial Distribution

  • 08031527017334 ()
K379

  • Electrocardiographic ambulatory recorder

SPIDERVIEW - 08031527015149

No Description
MICROPORT CRM SRL
Pouch
In Commercial Distribution

  • 08031527015149 ()


  • Electrocardiographic ambulatory recorder

CUSTODIA - 08031527015132

No Description
MICROPORT CRM SRL
SPIDERVIEW
In Commercial Distribution

  • 08031527015132 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW - 08031527014890

No Description
MICROPORT CRM SRL
PLUS
In Commercial Distribution

  • 08031527014890 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW+ SD MEMORY CARD - 08031527014883

No Description
MICROPORT CRM SRL
SD Card
In Commercial Distribution

  • 08031527014883 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW - 08031527014876

No Description
MICROPORT CRM SRL
SPIDERVIEW
In Commercial Distribution

  • 08031527014876 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW & SPIDERFLASH-T MEMORY CARD - 08031527013428

No Description
MICROPORT CRM SRL
SD Card
In Commercial Distribution

  • 08031527013428 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW SD MEMORY CARD - 08031527013411

No Description
MICROPORT CRM SRL
SD card
In Commercial Distribution

  • 08031527013411 ()


  • Electrocardiographic ambulatory recorder

SPIDERVIEW - 08031527013398

No Description
MICROPORT CRM SRL
SPIDERVIEW
In Commercial Distribution

  • 08031527013398 ()


  • Electrocardiographic ambulatory recorder

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

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

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

7LS - 00031262096265

ReNew Light Therapy
FKA DISTRIBUTING CO., LLC
FA7-1450J
In Commercial Distribution

  • 00031262096265 ()
FA7-1450J

  • Red/blue light phototherapy unit

SICAT Function - D77664556410

Radiological visualization software for diagnosis and dental treatment planning
SiCAT GmbH & Co. KG
6455641
Not in Commercial Distribution

  • D77664556410 ()
6455641

  • Diagnostic x-ray digital imaging system workstation

SICAT Suite - D77664556330

No Description
SiCAT GmbH & Co. KG
6455633
Not in Commercial Distribution

  • D77664556330 ()
6455633

  • 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

SEER - 00840682116886

SEER 1000 PC APPLICATION
Ge Medical Systems Information Technologies, Inc.
1000 PC Application
In Commercial Distribution

  • 00840682116886 ()


  • Electrocardiographic ambulatory recorder

SEER - 00840682116879

SEER 1000 IOS APPLICATION
Ge Medical Systems Information Technologies, Inc.
1000 IOS Application
In Commercial Distribution

  • 00840682116879 ()


  • Electrocardiographic ambulatory recorder
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