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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 - 04260167482521

ESO Catheter, SD Small
Given Imaging, Inc.
RFG-3886
In Commercial Distribution

  • 04260167482521 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482507

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

  • 04260167482507 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482484

ESO Catheter
Given Imaging, Inc.
1286
In Commercial Distribution

  • 04260167482484 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482460

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

  • 04260167482460 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 04260167482446

ESO Z Catheter
Given Imaging, Inc.
3890
In Commercial Distribution

  • 04260167482446 ()


  • 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 - 04260167482200

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

  • 04260167482200 ()
  • 10884521742741 ()


  • Manometric gastrointestinal motility analysis system

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

Spacelabs Healthcare - 10841522107962

LIFECARD CF 12 REC US
SPACELABS HEALTHCARE (WASHINGTON), INC
LCF
Not in Commercial Distribution

  • 10841522107962 ()
LC12US

  • Electrocardiographic ambulatory recorder

Lifecard - 10841522107955

12 LEAD UPGRADE KIT, AHA CODE, LC12
SPACELABS HEALTHCARE (WASHINGTON), INC
Lifecard
Not in Commercial Distribution

  • 10841522107955 ()
LC12KITUS

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522107931

LIFECARD CF 12 REC EU
SPACELABS HEALTHCARE (WASHINGTON), INC
LCF
Not in Commercial Distribution

  • 10841522107931 ()
LC12

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522106910

CARDIOCONNECT KIT
SPACELABS HEALTHCARE (WASHINGTON), INC
CCONNECT
Not in Commercial Distribution

  • 10841522106910 ()
CCT

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522106699

4 ELECTRODE EVO RECORDER BELT MOUNTED
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522106699 ()
50-0035

  • Electrocardiographic ambulatory recorder

Lifecard - 10841522131103

256 MB COMPACT FLASH CARD
SPACELABS HEALTHCARE (WASHINGTON), INC
Compact Flash Card
In Commercial Distribution

  • 10841522131103 ()
CFC256MB

  • Electrocardiographic ambulatory recorder

Lifecard - 10841522131097

90 MB COMPACT FLASH CARD
SPACELABS HEALTHCARE (WASHINGTON), INC
Compact Flash Card
In Commercial Distribution

  • 10841522131097 ()
CFC90MB

  • Electrocardiographic ambulatory recorder

Eclipse Pro - 10841522129810

ECLIPSE PRO RECORDER,USA
SPACELABS HEALTHCARE (WASHINGTON), INC
Eclipse Pro
In Commercial Distribution

  • 10841522129810 ()
98700-USA

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522103391

EVO DOCKING STATION USB CONN & US CBL
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522103391 ()
50-0045

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522103384

EVO DOCKING STATION USB CONN & EU PWR CBL
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522103384 ()
50-0044

  • Electrocardiographic ambulatory recorder

Spacelabs Healthcare - 10841522103377

4 ELECTRODE EVO RECORDER PACKED
SPACELABS HEALTHCARE (WASHINGTON), INC
TAY
Not in Commercial Distribution

  • 10841522103377 ()
50-0034

  • Electrocardiographic ambulatory recorder

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 - 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 - 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

C015 - 08053470960017

Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic images
MICRONICA SRL
FP XL C015
In Commercial Distribution

  • 08053470960017 ()


  • Diagnostic x-ray digital imaging system workstation

C015 - 08053470960000

Interventional fluoroscopic x-ray system for processing and real-time treatment of fluoroscopic images
MICRONICA SRL
FP XS C015
In Commercial Distribution

  • 08053470960000 ()


  • Diagnostic x-ray digital imaging system workstation

Neutrogena - 00070501302743

Light therapy acne mask
Kenvue Brands LLC
00070501302743
Not in Commercial Distribution

  • 00070501302743 ()


  • Red/blue light phototherapy unit

Neutrogena - 00070501260395

Light therapy acne mask
Kenvue Brands LLC
00070501260395
Not in Commercial Distribution

  • 00070501260395 ()


  • Red/blue light phototherapy unit

Neutrogena - 00070501260364

Light therapy acne mask
Kenvue Brands LLC
00070501260364
Not in Commercial Distribution

  • 00070501260364 ()


  • Red/blue light phototherapy unit

Neutrogena - 00070501101315

Light Therapy Acne Spot Treatment
Kenvue Brands LLC
00070501101315
Not in Commercial Distribution

  • 00070501101315 ()


  • Red/blue light phototherapy unit

Neutrogena - 00070501101261

Light Therapy Acne Mask Activator
Kenvue Brands LLC
00070501101261
Not in Commercial Distribution

  • 00070501101261 ()


  • Red/blue light phototherapy unit

Neutrogena - 00070501101247

Light Therapy Acne Mask
Kenvue Brands LLC
00070501101247
Not in Commercial Distribution

  • 00070501101247 ()


  • Red/blue light phototherapy unit

Blue2 4th Generation - 00186648000609

No Description
Ablenet, Inc.
10000033
In Commercial Distribution

  • 00186648000609 ()
10000033

  • Assistive human interface device proximal control, hand-operated

Messenger - 00086001142550

Messenger 6.0.0 Software Release
SPOK INC.
6.0.0
In Commercial Distribution

  • 00086001142550 ()


  • Alarm application software

coDiagnostiX - D835CODX1

Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation

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 - 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 - 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 - 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

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
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