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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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BTL Unison applicator - B108284AP01ENUS0100

No Description
BTL INDUSTRIES LIMITED
BTL-284-01
In Commercial Distribution

  • B108284AP01ENUS0100 ()


  • Multi-modality hyperthermia system

EMTONE applicator - B108284AP01EMTENUS0100

No Description
BTL INDUSTRIES LIMITED
BTL-284-01
In Commercial Distribution

  • B108284AP01EMTENUS0100 ()


  • Multi-modality hyperthermia system

Aligned Medical Solutions - B098AMS1985B0

Hysteroscopy Pack
Aligned Medical Solutions
AMS1985B
In Commercial Distribution

  • B098AMS1985B1 ()
  • B098AMS1985B0 ()
AMS1985B

  • Rectal ultrasound navigational image processor

Vital Health Links - G122LS802GP0

Cellular enabled blood pressure monitor
Vital Health Links LLC
LS802GP
In Commercial Distribution

  • G122LS802GP0 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

IDEA Health - G057IDBP8080

No Description
IDEA HEALTH LLC
ID-BP808
In Commercial Distribution

  • G057IDBP8081 ()
  • G057IDBP8080 ()
  • G057IDBP8082 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Actiwave - B329AWVC23

Ambulatory ECG recorder with accelerometer - single channel
CAMNTECH LIMITED
Cardio
Not in Commercial Distribution

  • B329AWVC23 ()
08-603

  • Telemetric electrocardiographic ambulatory recorder

Actiwave - B329AWV04E22

Ambulatory ECG/EEG recorder - four channel
CAMNTECH LIMITED
4E
Not in Commercial Distribution

  • B329AWV04E22 ()
08-557

  • Telemetric electrocardiographic ambulatory recorder

Actiwave - B329AWV02M25

Ambulatory Electromyogram (EMG) - two channel
CAMNTECH LIMITED
2M
Not in Commercial Distribution

  • B329AWV02M25 ()
08-536

  • Telemetric electrocardiographic ambulatory recorder

Actiwave - B329AWV02E25

Ambulatory ECG/EEG recorder - two channel
CAMNTECH LIMITED
2E
Not in Commercial Distribution

  • B329AWV02E25 ()
08-521

  • Telemetric electrocardiographic ambulatory recorder

Actiwave - B329AWV01E22

Ambulatory ECG/EEG recorder - single channel
CAMNTECH LIMITED
1E
Not in Commercial Distribution

  • B329AWV01E22 ()
08-514

  • Telemetric electrocardiographic ambulatory recorder
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