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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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The Globus Volta X device is a programmable electro stimulator with multiple uses: Powered Muscle Stimulators, Transcutaneous Electrical Nerve Stimulator. Premodulated Current Therapy Stimulator, and Microcurrent Therapy Stimulator.
DOMINO SRL
VOLTA X
In Commercial Distribution

  • 08032625822868 ()
G7096

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
AIRFLOW PLUS
E.M.S. Electro Medical Systems S.A.
DV-165/X
In Commercial Distribution

  • 07613353208264 ()


  • Dental abrasive powder
SW000795 NGTELL7x-S Telligence Bridge Software, v7.4+
Ascom (Sweden) AB
7.x
In Commercial Distribution

  • 17350088671426 ()


  • Nurse call system
No Description
H & O Equipments SA
CryoProbe X+
In Commercial Distribution

  • 15407008481114 ()
S-HO-CXPRP-02

  • General cryosurgical system, cryogen gas, mechanical
No Description
H & O Equipments SA
CryoProbe X+
In Commercial Distribution

  • 15407008481107 ()
S-HO-CXPRP-01

  • General cryosurgical system, cryogen gas, mechanical
CADDIE is cloud based artificial intelligence medical device software. CADDIE interfaces with the video feed generated by an endoscopic video processor during a colonoscopy procedure. The software is intended to be used by trained and qualified healthcare professionals as an accompaniment to video endoscopy for the purpose of drawing attention to regions with visual characteristics consistent with colonic mucosal lesions (such as polyps and adenomas). CADDIE analyses the data from the endoscopic video processor in real-time and provides information to aid the endoscopist in detecting suspected colorectal polyps, if they are in the field of view of the endoscope. The areas highlighted by CADDIE are not to be interpreted as definite polyps or adenomas. The responsibility to make a decision as to whether or not a highlighted region contains a polyp or is an adenoma lies with the user. The endoscopist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp and its classification based on their own medical judgement.
ODIN MEDICAL LIMITED
v1.4.x
In Commercial Distribution

  • 15065010840024 ()


  • Endoscopic video image interpretive software
NEEDLE HOLDER TROUTMAN W/LOCK
Bausch & Lomb Incorporated
E3839 X
In Commercial Distribution

  • 00757770429882 ()


  • Suturing needle holder, reusable
NEEDLE HOLDER CURVED STORZ
Bausch & Lomb Incorporated
E3797 X
In Commercial Distribution

  • 00757770415205 ()


  • Suturing needle holder, reusable
Endodrill Drive System is to be used with Endodrill Biopsy Instrument GI . Endodrill System is a surgical instrument used together with a flexible ultrasound endoscope to collect tissue for histological examination.
Bibbinstruments AB
Model X
In Commercial Distribution

  • 17340179900078 ()
3000-01

  • General-purpose endoscopic needle, single-use
Dental ultrasonic surgical system
Guilin Woodpecker Medical Instrument Co., Ltd.
PIEZOART X
In Commercial Distribution

  • 06944843605807 ()


  • Dental ultrasonic surgical system
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