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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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Aligned Medical Solutions - B098AMS1985B0

Hysteroscopy Pack
Aligned Medical Solutions
AMS1985B
In Commercial Distribution

  • B098AMS1985B1 ()
  • B098AMS1985B0 ()
AMS1985B

  • Rectal ultrasound navigational image processor

Actiwave - B329AWV04E22

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

  • B329AWV04E22 ()
08-557

  • 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

Actiheart - B329AHBT56

Ambulatory ECG recorder with acclerometer - single channel
CAMNTECH LIMITED
AH5 BT
In Commercial Distribution

  • B329AHBT56 ()
18-505

  • Telemetric electrocardiographic ambulatory recorder

Actiwave - B329AWVC23

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

  • B329AWVC23 ()
08-603

  • 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 - B329AWV01E22

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

  • B329AWV01E22 ()
08-514

  • Telemetric electrocardiographic ambulatory recorder

Actiheart - B329AH556

Ambulatory ECG recorder with acclerometer - single channel
CAMNTECH LIMITED
AH5
In Commercial Distribution

  • B329AH556 ()
18-500

  • Telemetric electrocardiographic ambulatory recorder

Actiheart - B329AH420

Ambulatory ECG recorder with acclerometer - single channel
CAMNTECH LIMITED
AH4
Not in Commercial Distribution

  • B329AH420 ()
08-305

  • Telemetric electrocardiographic ambulatory recorder

EMSCULPT NEO - B108899PO11C1ENUS0150

No Description
BTL INDUSTRIES LIMITED
EMSCULPT NEO
In Commercial Distribution

  • B108899PO11C1ENUS0150 ()


  • Multi-modality hyperthermia system
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