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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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InTENSity at Home OTC TENS device with 12 preset programs and 100 Intensity levels
COMPASS HEALTH BRANDS CORP.
E200-6R
In Commercial Distribution

  • 30092237619590 ()
  • 00092237619599 ()
  • 80092237619595 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2630-9601-3 G
In Commercial Distribution

  • 04049016083283 ()


  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
operating table, compatible with REF 30-700-00 & 40-337-00
Spiggle & Theis Medizintechnik GmbH
30-700-01
In Commercial Distribution

  • 04250676733788 ()
30-700-01

  • Surgical instrument assist arm system, manually-adjusted
Aperio ePathology IVD System AT Turbo, includes; AT Turbo IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500
LEICA BIOSYSTEMS IMAGING, INC
23ATTIVD-2500
In Commercial Distribution

  • 00815477020068 ()

  • Device Size Text, specify:


  • Multi-modality clinical specimen analysis system IVD
Inogen At Home Stationary Concentrator, CE (10-06316-XX-XX)
Inogen, Inc.
CE
In Commercial Distribution

  • 00817131020148 ()
GS-100

  • Stationary oxygen concentrator
Inogen At Home Stationary Concentrator, NCE (10-05345-XX-XX)
Inogen, Inc.
NCE
In Commercial Distribution

  • 00817131020131 ()
GS-100

  • Stationary oxygen concentrator
No Description
TALLADIUM, INC.
5147-MLAT-D3
In Commercial Distribution

  • D7915147MLATD30 ()
5147-MLAT-D3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-D2
In Commercial Distribution

  • D7915147MLATD20 ()
5147-MLAT-D2

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-C3
In Commercial Distribution

  • D7915147MLATC30 ()
5147-MLAT-C3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-C2
In Commercial Distribution

  • D7915147MLATC20 ()
5147-MLAT-C2

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-C1
In Commercial Distribution

  • D7915147MLATC10 ()
5147-MLAT-C1

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-B2
In Commercial Distribution

  • D7915147MLATB20 ()
5147-MLAT-B2

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-B1
In Commercial Distribution

  • D7915147MLATB10 ()
5147-MLAT-B1

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-A3.5
In Commercial Distribution

  • D7915147MLATA350 ()
5147-MLAT-A3.5

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5147-MLAT-A3
In Commercial Distribution

  • D7915147MLATA30 ()
5147-MLAT-A3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5144-MLAT-D3
In Commercial Distribution

  • D7915144MLATD30 ()
5144-MLAT-D3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
5144-MLAT-C3
In Commercial Distribution

  • D7915144MLATC30 ()
5144-MLAT-C3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19820-OFAML-D3
In Commercial Distribution

  • D79119820OFAMLD30 ()
19820-OFAML-D3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19820-ATML-D3
In Commercial Distribution

  • D79119820ATMLD30 ()
19820-ATML-D3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19820-ATML-D2
In Commercial Distribution

  • D79119820ATMLD20 ()
19820-ATML-D2

  • Dental appliance fabrication material, ceramic
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