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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e-vive II NMES System; 2XL/3XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-315I
In Commercial Distribution

  • 00850022650086 ()

  • Length: 16 Inch
CY-1000-315I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System; L/XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-314I
In Commercial Distribution

  • 00850022650079 ()

  • Length: 16 Inch
CY-1000-314I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System; S/M, Right (ITALIAN)
Motive Health, Inc.
CY-1000-313I
In Commercial Distribution

  • 00850022650062 ()

  • Length: 16 Inch
CY-1000-313I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System; 2XL/3XL, Left (ITALIAN)
Motive Health, Inc.
CY-1000-318I
In Commercial Distribution

  • 00850022650116 ()

  • Length: 16 Inch
CY-1000-318I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System; L/XL, Left (ITALIAN)
Motive Health, Inc.
CY-1000-317I
In Commercial Distribution

  • 00850022650109 ()

  • Length: 16 Inch
CY-1000-317I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
e-vive II NMES System; S/M, Left (ITALIAN)
Motive Health, Inc.
CY-1000-316I
In Commercial Distribution

  • 00850022650093 ()

  • Length: 16 Inch
CY-1000-316I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Kit. Italian
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-05 I
In Commercial Distribution

  • D801ID6005I1 ()
60-05

  • Dentine adhesive
CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Syringe. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 60-051 I
In Commercial Distribution

  • D801ID60051I1 ()
60-05

  • Dentine adhesive
CS300 Intra-Aortic Balloon Pump, Refurbished, ITALIAN,NON-UTS,INTL
Datascope Corp.
0998-UC-3023-67
In Commercial Distribution

  • 10607567108810 ()
0998-UC-3023-67

  • Intra-aortic balloon pump
CS100 Intra-Aortic Balloon Pump, Refurbished, ITALIAN,NON-UTS,INTL
Datascope Corp.
0998-UC-3013-67
Not in Commercial Distribution

  • 10607567108681 ()
0998-UC-3013-67

  • Intra-aortic balloon pump
800 Series Options Kit, Italian, 840 Neonatal Ventilator
Covidien LP
10051463
Not in Commercial Distribution

  • 10884521640887 ()


  • Ventilator application software
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MAXI - Verde
In Commercial Distribution

  • 08052675320091 ()
IT17-001V

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MAXI - Rosso
In Commercial Distribution

  • 08052675320084 ()
IT17-001R

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MAXI - Giallo
In Commercial Distribution

  • 08052675320077 ()
IT17-001G

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica MAXI Blu
In Commercial Distribution

  • 08052675320060 ()
IT17-001B

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MAXI - Bianco
In Commercial Distribution

  • 08052675320053 ()
IT17-001

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MINI - Verde
In Commercial Distribution

  • 08052675320046 ()
IT17-002V

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MINI - Rosso
In Commercial Distribution

  • 08052675320039 ()
IT17-002R

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MINI - Giallo
In Commercial Distribution

  • 08052675320022 ()
IT17-002G

  • Orthodontic extraoral headgear
No Description
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Maschera facciale ortodontica - MINI - Blu
In Commercial Distribution

  • 08052675320015 ()
IT17-002B

  • Orthodontic extraoral headgear
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

  • 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
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
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
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