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 Class Implantable

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No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MINI - Bianco
In Commercial Distribution

  • 08052675320008 ()
IT17-002

  • Orthodontic extraoral headgear
Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Italian
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(ITA)
In Commercial Distribution

  • 00850063034241 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Italian
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(ITA)
In Commercial Distribution

  • 00850015266874 ()
  • 00851113007949 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Sleep Profiler LE Device Kit (Arm&Chin EMG) Italian
ADVANCED BRAIN MONITORING, INC.
SP29-1014.LE(ITA)
In Commercial Distribution

  • 00850015266607 ()


  • Electroencephalograph
Compact Series Ultrasound System Cart
Philips Ultrasound LLC
989606735271
In Commercial Distribution

  • 00884838111981 ()


  • General-purpose ultrasound imaging system
Compact Series Ultrasound System Cart
Philips Ultrasound LLC
989606735151
In Commercial Distribution

  • 00884838111868 ()


  • General-purpose ultrasound imaging system
Compact Series Ultrasound System Cart
Philips Ultrasound LLC
989606735021
In Commercial Distribution

  • 00884838111738 ()


  • General-purpose ultrasound imaging system
No Description
BELMONT INSTRUMENT CORPORATION
902-00001A-I
Not in Commercial Distribution

  • 50896128002133 ()


  • Extravascular-circulation hyperthermia system
Visible Light-Cured Restorative, Resin Based. Universal Bonding Agent. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-121 I
In Commercial Distribution

  • D801ID50121I1 ()
50-121

  • Dental composite resin
self-contained biological indicator, 10e6 population, 100-count box printed in Italian
MESA LABORATORIES, INC.
10e6
In Commercial Distribution

  • M985IDSEZS61 ()
  • M985IDSEZS60 ()
IDSEZS/6

  • Biological sterilization indicator
self-contained biological indicator, 10e6 population, 100-count box printed in Italian
MESA LABORATORIES, INC.
10e6
In Commercial Distribution

  • M985IDEZS61 ()
  • M985IDEZS60 ()
IDEZS/6

  • Biological sterilization indicator
self-contained biological indicator, 10e5 population, 100-count box printed in Italian
MESA LABORATORIES, INC.
10e5
In Commercial Distribution

  • M985IDEZS51 ()
  • M985IDEZS50 ()
IDEZS/5

  • Biological sterilization indicator
e-vive II NMES System with Post-Op Brace; 2XL/3XL, Left (ITALIAN)
Motive Health, Inc.
CY-1000-312I
In Commercial Distribution

  • 00850022650055 ()

  • Length: 16 Inch
CY-1000-312I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; L/XL, Left (ITALIAN)
Motive Health, Inc.
CY-1000-311I
In Commercial Distribution

  • 00850022650048 ()

  • Length: 16 Inch
CY-1000-311I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; S/M, Left (ITALIAN)
Motive Health, Inc.
CY-1000-310I
In Commercial Distribution

  • 00850022650031 ()

  • Length: 16 Inch
CY-1000-310I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; 2XL/3XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-309I
In Commercial Distribution

  • 00850022650024 ()

  • Length: 16 Inch
CY-1000-309I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; L/XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-308I
In Commercial Distribution

  • 00850022650017 ()

  • Length: 16 Inch
CY-1000-308I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System with Post-Op Brace; S/M, Right (ITALIAN)
Motive Health, Inc.
CY-1000-307I
In Commercial Distribution

  • 00850022650000 ()

  • Length: 16 Inch
CY-1000-307I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Enamel Primer Bottle. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-052 I
In Commercial Distribution

  • D801ID60052I1 ()
60-052

  • Dentine adhesive
IDS Dental Polishing Paste for Composite Restoratives, Amalgams, and Castings. Italian
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-05
In Commercial Distribution

  • D801ID5005I1 ()
50-05

  • Dentifrice
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