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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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PaX-i3D - 08800016400243

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru1215CF / 1210SGA)
VATECH CO., LTD.
PHT-6500
Not in Commercial Distribution

  • 08800016400243 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D - 08800016400236

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru1215CF / Xmaru2301CF)
VATECH CO., LTD.
PHT-6500
In Commercial Distribution

  • 08800016400236 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D - 08800016400212

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru0712CF / 910SGA)
VATECH CO., LTD.
PHT-6500
Not in Commercial Distribution

  • 08800016400212 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400144

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru1524CF(H) / 910SGA)
VATECH CO., LTD.
PHT-60CFO
In Commercial Distribution

  • 08800016400144 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400083

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru1524CF(V) / Xmaru2301CF)
VATECH CO., LTD.
PHT-60CFO
Not in Commercial Distribution

  • 08800016400083 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D Green - 08800016400069

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru1215CF / 910SGA)
VATECH CO., LTD.
PHT-60CFO
Not in Commercial Distribution

  • 08800016400069 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

CROMA Electrosurgical Generator - 05060359561206

The CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered Electrosurgical Unit (ESU). The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories. The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.
CREO MEDICAL LIMITED
PRD-EMR-050
In Commercial Distribution

  • 05060359561213 ()
  • 05060359561206 ()
PRD-EMR-050

  • Microwave/electrosurgical system generator

Reusable Interface Cable, 1.5 m - 05060359560834

The Reusable Interface Cable is only for connection of compatible Creo Medical Instruments (Surgical Accessories) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave energy for the cutting, coagulation and ablation via endoscopic access.
CREO MEDICAL LIMITED
PRD-IFC-002
In Commercial Distribution

  • 05060359560629 ()
  • 05060359560834 ()

  • Length: 1.5 Meter
PRD-IFC-002

  • Electrical-only medical device connection cable, reusable

Croma - 05060359560223

HS1 is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites will include the following • Peptic Ulcers • Dieulafoy Lesions • Mallory-Weiss Tears • Bleeding Polyp Stalks • Arteriovenous Malformations (AVMs) • Angiomata The HS1 also has irrigation capability. Any other use is not recommended.
CREO MEDICAL LIMITED
Slypseal Flex
In Commercial Distribution

  • 05060359560223 ()
  • 05060359560216 ()

  • Length: 1.8 Meter
  • Outer Diameter: 3.2 Millimeter
7-HS1-001

  • Endoscopic microwave ablation probe/needle

Sweet Dreamers - 05060216820569

Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8813C
Not in Commercial Distribution

  • 15060216820566 ()
  • 05060216820569 ()


  • Infrared patient thermometer, skin

Sleep Profiler PSG2 - 00850015266997

Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Swiss
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(SWISS)
In Commercial Distribution

  • 00850015266997 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph

Sleep Profiler PSG2 - 00850015266980

Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) German
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(GER)
In Commercial Distribution

  • 00850015266980 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system

Sleep Profiler PSG2 - 00850015266973

Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Swiss
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(SWISS)
In Commercial Distribution

  • 00850015266973 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system

Sleep Profiler - 00850015266966

Sleep Profiler LE Device Kit Swiss
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(SWISS)
In Commercial Distribution

  • 00850015266966 ()


  • Electroencephalograph

Sleep Profiler - 00850015266959

Sleep Profiler LE Device Kit French
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(FRE)
In Commercial Distribution

  • 00850015266959 ()


  • Electroencephalograph

Sleep Profiler PSG2 - 00850015266942

Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) French
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(FRE)
In Commercial Distribution

  • 00850015266942 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system

X-Series - 00850015266898

X24 LE Stat Device Kit Stratus
ADVANCED BRAIN MONITORING, INC.
XS30-1006.LE
In Commercial Distribution

  • 00850015266249 ()
  • 00850015266898 ()


  • Electroencephalograph

X-Series - 00850015266690

X24 LE Stat Device Kit Clinical
ADVANCED BRAIN MONITORING, INC.
XS30-1007.LE
In Commercial Distribution

  • 00850015266249 ()
  • 00850015266690 ()


  • Electroencephalograph

X-Series - 00850015266683

X24 LE Stat Device Kit
ADVANCED BRAIN MONITORING, INC.
XS30-1001.LE
In Commercial Distribution

  • 00850015266683 ()
  • 00850015266249 ()


  • Electroencephalograph

Sleep Profiler - 00850015266676

Sleep Profiler LE Device Kit Dutch
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(DUT)
In Commercial Distribution

  • 00850015266676 ()


  • Electroencephalograph

Sleep Profiler PSG2 - 00850015266669

Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Italian with cables
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(ITA)
In Commercial Distribution

  • 00850015266669 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph

Sleep Profiler - 00850015266607

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 - 00850015266546

Sleep Profiler PSG2 LE Device Kit No Belts (PM3) German
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(GER)
In Commercial Distribution

  • 00850015266546 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph

Sleep Profiler - 00850015266539

Sleep Profiler LE Device Kit German
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(GER)
In Commercial Distribution

  • 00850015266539 ()


  • Electroencephalograph

Sleep Profiler PSG2 - 00850015266256

Sleep Profiler PSG2 LE Device Kit (No Belts / PM3) with cables
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE, SP29-1007.LE
In Commercial Distribution

  • 00850015266256 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph

Myocene - 05430004268000

The Myocene device is intended to provide objective measures of muscle fatigue to inform athletic training decisions by coaches and athletes. It is for applications in sport practice, to be used on healthy individuals (athletes), 15 years of age or older, to carry out tests of the extensor muscles of the knee by quantitatively measuring the force of contraction of the healthy quadriceps muscles generated by voluntary contractions and induced by a specific associated powered muscle stimulator, and by using these forces to compute objective measures of quadriceps muscle fatigue
Myocene
1-U
In Commercial Distribution

  • 05430004268000 ()


  • Quadriceps fatigue electrostimulation analyser

Cefaly® - 05425018850334

Indications for Use: CEFALY Connected is indicated to be used for: Acute treatment of migraine with or without aura in patients 18 years of age or older. Prophylactic treatment of migraine in patients 18 years of age or older.
Cefaly Technology SPRL
CEFALY Connected Bundle VA
In Commercial Distribution

  • 05425018850334 ()
10811

  • Craniofacial analgesia electrical stimulator

Cefaly® - 05425018850297

CEFALY Connected is indicated to be used for: Acute treatment of migraine with or without aura in patients 18 years of age or older. Preventative treatment of migraine in patients 18 years of age or older.
Cefaly Technology SPRL
CEFALY Connected
In Commercial Distribution

  • 05425018850297 ()
10801

  • Craniofacial analgesia electrical stimulator

Cefaly® - 05425018850280

CEFALY Enhanced is for patients diagnosed by a physician with migraines per the FDA cleared indications for use. CEFALY Enhanced is indicated to be used for: Acute treatment of migraine with or without aura in patients 18 years of age or older. Preventative treatment of migraine in patients 18 years of age or older.
Cefaly Technology SPRL
CEFALY Enhanced
In Commercial Distribution

  • 05425018850280 ()
10701

  • Craniofacial analgesia electrical stimulator

Cefaly® - 05425018850273

Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA - cleared device Indications for Use: CEFALY DUAL Enhanced is for patients diagnosed by a physician with migraines per the FDA cleared indications for use. CEFALY DUAL Enhanced is indicated to be used for: The acute treatment of migraine with or without aura in patients 18 years of age or older. The preventative treatment of episodic migraine in patients 18 years of age or older.
Cefaly Technology SPRL
CEFALY DUAL Enhanced
In Commercial Distribution

  • 05425018850273 ()
10601

  • Craniofacial analgesia electrical stimulator
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