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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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Mahana IBS - 00860006172015

Mahana IBS is a prescription Digital Therapeutic (PDT) mobile application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS).
Mahana Therapeutics, Inc.
01-0003-001
In Commercial Distribution

  • 00860006172015 ()
01-0003-001

  • Mental health/function therapeutic software, screen-viewed

KONQUEST - 00869378000445

DIGITAL WRIST BLOOD PRESSURE MONITOR
KONQUEST GROUP INC
KBP-2910W
In Commercial Distribution

  • 00869378000445 ()


  • Patient monitoring system module, blood pressure, noninvasive

KONQUEST - 00869378000438

DIGITAL ARM BLOOD PRESSURE MONITOR
KONQUEST GROUP INC
KBP-2704A
In Commercial Distribution

  • 00869378000438 ()


  • Patient monitoring system module, blood pressure, noninvasive

ALLY - 00867744000150

No Description
LENSAR, Inc.
70-00050-001
In Commercial Distribution

  • 10867744000157 ()
  • 00867744000150 ()
N/A

  • Femtosecond ophthalmic solid-state laser system

LENSAR LLS-fs 3D - 00867744000112

No Description
LENSAR, Inc.
70-00013-001
In Commercial Distribution

  • 10867744000119 ()
  • 00867744000112 ()


  • Femtosecond ophthalmic solid-state laser system

LENSAR LLS-fs 3D - 00867744000105

No Description
LENSAR, Inc.
70-00005-001
In Commercial Distribution

  • 10867744000102 ()
  • 00867744000105 ()


  • Femtosecond ophthalmic solid-state laser system

Finapres - 08719327007129

Height Correction Unit NC
Finapres Medical Systems B.V.
Height Correction Unit NC
In Commercial Distribution

  • 08719327007129 ()
FP_903903

  • Patient monitoring system module, blood pressure, noninvasive

Finapres - 08719327007112

No Description
Finapres Medical Systems B.V.
Finapres NOVA Frontend Unit NC
In Commercial Distribution

  • 08719327007112 ()
FP_910804

  • Patient monitoring system module, blood pressure, noninvasive

Finapres - 08719327007105

Finapres NOVA Main Unit NC
Finapres Medical Systems B.V.
Finapres NOVA Main Unit NC
In Commercial Distribution

  • 08719327007105 ()
FP_910804

  • Patient monitoring system module, blood pressure, noninvasive

Finapres - 08719327003794

Finger cuff size Small NC
Finapres Medical Systems B.V.
Finger cuff size Small NC
In Commercial Distribution

  • 08719327003794 ()
FP_400222

  • Patient monitoring system module, blood pressure, noninvasive
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