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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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ManoScan - 04260167482439

ESO With Extended Tip
Given Imaging, Inc.
800015
In Commercial Distribution

  • 04260167482439 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482422

ESO 3D Catheter
Given Imaging, Inc.
FGS-8001
In Commercial Distribution

  • 04260167482422 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482262

Assy, Retail Box of 20, ManoShield SD
Given Imaging, Inc.
MSS-4360
In Commercial Distribution

  • 04260167482262 ()
  • 10884521742727 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482248

Assy, Retail Box of 10, ManoShield AR
Given Imaging, Inc.
MSS-3599
In Commercial Distribution

  • 04260167482248 ()
  • 10884521742734 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482200

Assy, Retail Box of 20, ManoShield EG
Given Imaging, Inc.
MSS-2155
In Commercial Distribution

  • 04260167482200 ()
  • 10884521742741 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167480961

ESO Catheter, SD Regular
Given Imaging, Inc.
3887
In Commercial Distribution

  • 04260167480961 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167480954

AR 3D Probe
Given Imaging, Inc.
3885
In Commercial Distribution

  • 04260167480954 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167483719

MSS-4581-3D MANOSHIELD 3DAR - BOX 10
Given Imaging, Inc.
MSS-4581-3D
In Commercial Distribution

  • 04260167483719 ()
  • 10884521768062 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167483597

ESO Catheter, RFG
Given Imaging, Inc.
RFG-1286-EAN
In Commercial Distribution

  • 04260167483597 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482989

ESO Catheter, RFG
Given Imaging, Inc.
RFG-3890-EAN
In Commercial Distribution

  • 04260167482989 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482637

ESO 3D Catheter
Given Imaging, Inc.
RFG-8001
In Commercial Distribution

  • 04260167482637 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482552

AR Catheter, Regular
Given Imaging, Inc.
RFG-2192
In Commercial Distribution

  • 04260167482552 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482545

AR Catheter, Small
Given Imaging, Inc.
RFG-2195
In Commercial Distribution

  • 04260167482545 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482538

AR 3D Probe
Given Imaging, Inc.
RFG-3885
In Commercial Distribution

  • 04260167482538 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482514

ESO Catheter, SD Regular
Given Imaging, Inc.
RFG-3887
In Commercial Distribution

  • 04260167482514 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482491

ESO With Extended Tip
Given Imaging, Inc.
RFG-8000-15
In Commercial Distribution

  • 04260167482491 ()


  • Manometric gastrointestinal motility analysis system

Microlife - 04719003932053

No Description
MICROLIFE USA, INC.
CUFFM-WBPOANKLE
In Commercial Distribution

  • 14719003932050 ()
  • 04719003932053 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 04719003631284

No Description
MICROLIFE USA, INC.
BP3SZ1-1AFIB
In Commercial Distribution

  • 14719003631281 ()
  • 04719003631284 ()


  • Arrythmia-detection blood pressure ambulatory recorder

Microlife - 04719003315085

WBP Home A BT (BP3MX1-3C) with Universal Label for USA/EU/CA markets
MICROLIFE USA, INC.
CRO-BP3MX1-3C1
In Commercial Distribution

  • 04719003315085 ()
  • 14719003315082 ()
  • 24719003315089 ()
  • 34719003315086 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 04719003315047

WatchBP O3 2G(BP3SZ1-1) CBP type
MICROLIFE USA, INC.
BP3SZ1-1CEN
In Commercial Distribution

  • 14719003315044 ()
  • 04719003315047 ()
  • 24719003315041 ()
WatchBP O3 2G

  • Arrythmia-detection blood pressure ambulatory recorder

Microlife - 04719003315030

WatchBP O3 2G(BP3SZ1-1) Advanced type
MICROLIFE USA, INC.
BP3SZ1-1
In Commercial Distribution

  • 14719003315037 ()
  • 04719003315030 ()
  • 24719003315034 ()
WatchBP O3 2G

  • Arrythmia-detection blood pressure ambulatory recorder

Shark - 00622356086912

The CryoGlow is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles.
SharkNinja Operating LLC
CryoGlow
In Commercial Distribution

  • 00622356086912 ()


  • Red/blue light phototherapy unit

TelePatch Cardiac Monitor - 00862887000371

TelePatch CM PM700 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM700
Not in Commercial Distribution

  • 00862887000371 ()


  • Electrocardiographic ambulatory recorder

Decipher Holter Monitor - 00862887000364

Decipher Holter Monitor is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM461
Not in Commercial Distribution

  • 00862887000364 ()


  • Electrocardiographic ambulatory recorder

Cardiac Monitor - 00862887000357

Cardiac Monitor PM500 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM500
Not in Commercial Distribution

  • 00862887000357 ()


  • Electrocardiographic ambulatory recorder

CardioPAL SAVI - 00862887000340

CardioPAL SAVI is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM410
Not in Commercial Distribution

  • 00862887000340 ()


  • Electrocardiographic ambulatory recorder

Messenger - 00865190000304

Messenger 5.18 Software Release
SPOK INC.
5.18.0
In Commercial Distribution

  • 00865190000304 ()


  • Alarm application software

A.C.E Red and Blue - 00864918000336

LED light for the treatment of acne
PULSADERM LLC
PD9500
In Commercial Distribution

  • 00864918000336 ()


  • Red/blue light phototherapy unit

Blue LED Acne Clearing Light - 00864918000329

Blue LED Light for the treatment of mild to moderate acne
PULSADERM LLC
PD5000B
In Commercial Distribution

  • 00864918000329 ()


  • Red/blue light phototherapy unit

Pulsaderm RED LED Skin Renewal - 00864918000312

Red LED Light for Wrinkles
PULSADERM LLC
PD5000R
In Commercial Distribution

  • 00864918000312 ()


  • Red/blue light phototherapy unit

A.C.E Blue - 00864918000305

Blue Light for the treatment of acne
PULSADERM LLC
PD9505
In Commercial Distribution

  • 00864918000305 ()


  • Red/blue light phototherapy unit

Mui Scientific - 00678467004161

2 Channel Compressed Air SOM Pump
H & A Mui Enterprises Inc
PIP-5-2SS
Not in Commercial Distribution

  • 00678467004161 ()


  • Manometric gastrointestinal motility analysis system

Mui Scientific - 00678467003430

24 Channel Portable Compressed Air Manometric Pump
H & A Mui Enterprises Inc
P3-PIP-6-24SS
In Commercial Distribution

  • 00678467003430 ()


  • Manometric gastrointestinal motility analysis system

7LS - 00031262096265

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

  • 00031262096265 ()
FA7-1450J

  • Red/blue light phototherapy unit

C6 monitor - B146M10

No Description
BRAEMAR MANUFACTURING, LLC
100-0046-02
In Commercial Distribution

  • B146M10 ()


  • Electrocardiographic ambulatory recorder

ER9W Cardiolabs - B146ERWCD040

No Description
BRAEMAR MANUFACTURING, LLC
900-0612-04
In Commercial Distribution

  • B146ERWCD040 ()


  • Electrocardiographic ambulatory recorder

ePatch 2.0 rebuilt - B146EP2R10

No Description
BRAEMAR MANUFACTURING, LLC
02-01997
In Commercial Distribution

  • B146EP2R10 ()


  • Electrocardiographic ambulatory recorder

ePatch Sensor 2.5, Rebuilt - B146EP25R0

No Description
BRAEMAR MANUFACTURING, LLC
02-02251
In Commercial Distribution

  • B146EP25R0 ()


  • Electrocardiographic ambulatory recorder

ePatch 2.5, BTI - B146EP2520

No Description
BRAEMAR MANUFACTURING, LLC
02-02046
In Commercial Distribution

  • B146EP2520 ()


  • Electrocardiographic ambulatory recorder

ePatch 2.5, BTH - B146EP2510

No Description
BRAEMAR MANUFACTURING, LLC
02-02045
In Commercial Distribution

  • B146EP2510 ()


  • Electrocardiographic ambulatory recorder
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