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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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Bone Delivery Tower, Compact
Seaspine Orthopedics Corporation
ET2-106001
In Commercial Distribution

  • 10889981275532 ()
ET2-106001

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Universal Expansion Driver
Seaspine Orthopedics Corporation
ET2-101101
In Commercial Distribution

  • 10889981275525 ()
ET2-101101

  • Amniocentesis kit, medicated, reusable
Inserter, Explorer TO
Seaspine Orthopedics Corporation
ET2-101000
In Commercial Distribution

  • 10889981275518 ()
ET2-101000

  • Orthopaedic inorganic implant inserter/extractor, reusable
Torque Driver Adapter
Seaspine Orthopedics Corporation
ET2-001112
In Commercial Distribution

  • 10889981275501 ()
ET2-001112

  • Orthopaedic prosthesis implantation positioning instrument, reusable
CommunicationConsole is part of NordicNeuroLab’s Audio System. The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. The Communication Console allows the operator to adjust the sounds from the PC and to speak directly to the patient through a built-in microphone.
Nordicneurolab AS
CC 2.3
In Commercial Distribution

  • 07090042053044 ()


  • Auditory stimulator
The plate bender (6.5 threaded hole) is used to shape the plate according to the bone configuration.
NEWDEAL
219765ND
In Commercial Distribution

  • M248219765ND1 ()
  • 10381780052005 ()


  • Manual orthopaedic bender, reusable
The plate bender (3.5 threaded hole) is used to shape the plate according to the bone configuration.
NEWDEAL
219735ND
In Commercial Distribution

  • M248219735ND1 ()
  • 10381780051992 ()


  • Manual orthopaedic bender, reusable
The Non-Contact Tonometer is intended to be used to measure the intraocular pressure of the human eye.
Huvitz Co., Ltd.
HNT-1
In Commercial Distribution

  • 08800019600428 ()
HNT-1

  • Ophthalmic tonometer, battery-operated
The Non-Contact Tonometer is intended to be used to measure the intraocular pressure of the human eye.
Huvitz Co., Ltd.
HNT-7000
In Commercial Distribution

  • 08800019600176 ()
HNT-7000

  • Ophthalmic tonometer, battery-operated
The Auto Ref/Keratometer is intended to be used to measure the refractive power of the eye
Huvitz Co., Ltd.
HRK-9000A
In Commercial Distribution

  • 08800019600169 ()
HRK-9000A

  • Ophthalmic refractometer, manual
The Auto Ref/Keratometer is intended to be used to measure the refractive power of the eye
Huvitz Co., Ltd.
HRK-8000A
In Commercial Distribution

  • 08800019600152 ()
HRK-8000A

  • Ophthalmic refractometer, manual
The Auto Ref/Keratometer is intended to be used to measure the refractive power of the eye
Huvitz Co., Ltd.
HRK-7000A
In Commercial Distribution

  • 08800019600145 ()
HRK-7000A

  • Ophthalmic refractometer, manual
Radiofrequency devices. Accessory intended to transmit the electric current generated by the RF generator to the tips.
INDIBA SA.
ACC1018USA
In Commercial Distribution

  • 08434251002667 ()
REVERSO applicator handle

  • Intradermal radio-frequency ablation system
The Mitt is intended to be used to limit the movement of the patient's hands and fingers.
Kenad SG Medical, Inc.
Patient Protective Mitt with Stays Infant
In Commercial Distribution

  • M1435011201 ()
50-1120

  • Limb/torso/head restraint, single-use
The Mitt is intended to be used to limit the movement of the patient's hands and fingers.
Kenad SG Medical, Inc.
Protective Mitt with Stay Child
In Commercial Distribution

  • M1435011101 ()
50-1110

  • Limb/torso/head restraint, single-use
The Mitt is intended to be used to limit the movement of the patient's hands and fingers.
Kenad SG Medical, Inc.
Patient Protective Mitt Infant w/o Stays
In Commercial Distribution

  • M1435010201 ()
50-1020

  • Limb/torso/head restraint, single-use
The Mitt is intended to be used to limit the movement of the patient's hands and fingers.
Kenad SG Medical, Inc.
Patient Protective Mitt Child w/o Stays
In Commercial Distribution

  • M1435010101 ()
50-1010

  • Limb/torso/head restraint, single-use
The T2Candida components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel.
T2 BIOSYSTEMS, INC.
90-01794
Not in Commercial Distribution

  • M70890017940 ()


  • Multiple Candida species nucleic acid IVD, reagent
The FRAXION™ Frontpiece is attached to the FRAXION™ Frame in order to set-up the patient with the mouthpiece.
3C-Medical Intelligence GmbH
P10106-101
In Commercial Distribution

  • 04056719001360 ()
P10106-101

  • Stereotactic radiosurgical/radiotherapy arch head frame
The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exercise regime for Vestibular and Balance Rehabilitation. The Vertigenius™ system comprises a sensor that is worn behind the ear that detects head movement, a companion smart phone app and clinician platform. Vestibular rehabilitation exercises are prescribed by clinicians for their patient using the Vertigenius™ application platform. Vertigenius™ can be used with or without the head sensor. The companion app delivers the prescribed exercise regime, provides auditory and visual cues, tracks symptoms and monitors adherence. The head sensor is worn whilst the patient is carrying out specific prescribed head movement exercises for Vestibular and Balance Rehabilitation. It is used to provide real-time feedback to the patient so that they can see if they are carrying out the prescribed exercises correctly. The sensor and connected app provide feedback via the clinician platform to the prescribing clinician on the quality of exercise performance, changes in symptoms and adherence of the patient to the prescribed exercises, enabling the clinician to remotely monitor progress.
DIGITAL REHABILITATION LIMITED
VG01
In Commercial Distribution

  • 05391548420036 ()
  • 05391548420029 ()
  • 05391548420043 ()
VGHS01

  • Biomechanical function analysis/rehabilitation software
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