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 Class Implantable

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Smoke Filtration System (230 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
230VAC
In Commercial Distribution

  • H671SSE2000 ()
SSE-200

  • Surgical plume evacuation system
Smoke Filtration System (115 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
115VAC
In Commercial Distribution

  • H671SSE1000 ()
SSE-100

  • Surgical plume evacuation system
Origin Instant Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-THC
ORIGIN DIAGNOSTICS LLC
81026-OD-EI
In Commercial Distribution

  • B77881026ODEI0 ()
81026-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-OPI-OXY-THC
ORIGIN DIAGNOSTICS LLC
81025-OD-EI
In Commercial Distribution

  • B77881025ODEI0 ()
81025-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-BUP-BZO-COC-MET-MTD-OPI-OXY-THC
ORIGIN DIAGNOSTICS LLC
80902-OD-EI
In Commercial Distribution

  • B77880902ODEI0 ()
80902-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-BZO-COC-MET-OPI-THC
ORIGIN DIAGNOSTICS LLC
80600-OD-EI
In Commercial Distribution

  • B77880600ODEI0 ()
80600-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-BZO-COC-MET-OPI
ORIGIN DIAGNOSTICS LLC
80510-OD-EI
In Commercial Distribution

  • B77880510ODEI0 ()
80510-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-COC-MET-OPI-THC
ORIGIN DIAGNOSTICS LLC
80502-OD-EI
In Commercial Distribution

  • B77880502ODEI0 ()
80502-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-COC-MET-OPI
ORIGIN DIAGNOSTICS LLC
80409-OD-EI
In Commercial Distribution

  • B77880409ODEI0 ()
80409-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
61147-3-OD
In Commercial Distribution

  • B778611473OD0 ()
61147-3-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-PCP-THC
ORIGIN DIAGNOSTICS LLC
61025-OD
In Commercial Distribution

  • B77861025OD0 ()
61025-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
61013-3-OD
In Commercial Distribution

  • B778610133OD0 ()
61013-3-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-OXY-THC
ORIGIN DIAGNOSTICS LLC
61007-OD-OTC
In Commercial Distribution

  • B77861007ODOTC0 ()
61007-OD-OTC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-OXY-THC-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
61007-3-OD
In Commercial Distribution

  • B778610073OD0 ()
61007-3-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BZO-COC-MET-OPI-THC-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
60600-3-OD
In Commercial Distribution

  • B778606003OD0 ()
60600-3-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-COC-OPI-PCP-THC-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
60505-3-OD
In Commercial Distribution

  • B778605053OD0 ()
60505-3-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-COC-MET-OPI-THC
ORIGIN DIAGNOSTICS LLC
60500-OD-OTC
In Commercial Distribution

  • B77860500ODOTC0 ()
60500-OD-OTC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-COC-MET-OPI-THC-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
60500-3-OD
In Commercial Distribution

  • B778605003OD0 ()
60500-3-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-COC-MET-OPI-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
60440-3-OD
In Commercial Distribution

  • B778604403OD0 ()
60440-3-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Dip Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-THC
ORIGIN DIAGNOSTICS LLC
31236-OD
In Commercial Distribution

  • B77831236OD0 ()
31236-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Dip Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-PCP-TCA-THC
ORIGIN DIAGNOSTICS LLC
31016-OD
In Commercial Distribution

  • B77831016OD0 ()
31016-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Dip Drug Test, AMP-BUP-BZO-COC-MET-MTD-OPI300-OXY-THC
ORIGIN DIAGNOSTICS LLC
30940-OD
In Commercial Distribution

  • B77830940OD0 ()
30940-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Dip Drug Test, BZO-COC-MET-OPI300-THC
ORIGIN DIAGNOSTICS LLC
30573-OD
In Commercial Distribution

  • B77830573OD0 ()
30573-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Dip Drug Test, AMP-COC-MET-OPI-THC
ORIGIN DIAGNOSTICS LLC
30500-OD
In Commercial Distribution

  • B77830500OD0 ()
30500-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Unloading harness for gait training
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRUHS0 ()


  • Gait rehabilitation system harness
Bariatric Harness for persons 300-600 lbs
M.A.S.S. Rehab, LLC
Bariatric
In Commercial Distribution

  • G505MRUHB0 ()


  • Gait rehabilitation system harness
Pediatiric harness for gait training.
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRPH0 ()


  • Gait rehabilitation system harness
Simple two-loop spotting harness for gait and balance training.
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRMS0 ()


  • Gait rehabilitation system harness
Harness for Healing Solutions Robotic Trainer
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRHSH0 ()


  • Gait rehabilitation system harness
Balance harness for balance training activities
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRBHS0 ()


  • Gait rehabilitation system harness
GammaPro Straight Standard Probe for wireless ionizing radiation detection.
Kubtec
K0018C01
In Commercial Distribution

  • B619GPROSTDPROBE0 ()


  • Mobile gamma camera system
GammaPro Kit with Standard probe, Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0018C02
In Commercial Distribution

  • B619GPROSTDKIT0 ()


  • Mobile gamma camera system
GammaPro Angled Standard Probe used for wireless ionizing radiation detection.
Kubtec
K0021C01
In Commercial Distribution

  • B619GPROSTDANGPROBE0 ()


  • Mobile gamma camera system
GammaPro Laparoscopic Probe used for wireless ionizing radiation detection.
Kubtec
K0020C01
In Commercial Distribution

  • B619GPROLAPPROBE0 ()


  • Mobile gamma camera system
GammaPro Laparoscopic Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0020C02
In Commercial Distribution

  • B619GPROLAPKIT0 ()


  • Mobile gamma camera system
GammaPro High Sensitivity Probe used for wireless ionizing radiation detection.
Kubtec
K0019C01
In Commercial Distribution

  • B619GPROHISPROBE0 ()


  • Mobile gamma camera system
GammaPro Hi-Sense Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0019C02
In Commercial Distribution

  • B619GPROHISKIT0 ()


  • Mobile gamma camera system
Table with installed software is used with wireless battery powered probes (different shapes and sizes) to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity.
Kubtec
K0017C01
In Commercial Distribution

  • B619GPROCASETABL2 ()


  • Mobile gamma camera system
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. HEADSTAR is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus), the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests and the Video Head Impulse Test. HEADSTAR is a nystagmography system and is able to record movements of one eye: horizontal, vertical and rotary on option. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. HEADSTAR is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run VHIT tests and other oculomotor tests.
Instrumentation Difra SA
HeadStar V2.0
In Commercial Distribution

  • B516320980 ()
32098

  • Electronystagmograph
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution

  • B516311790 ()
31179

  • Electronystagmograph
  • Dynamic visual acuity testing system
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution

  • B516227090 ()
22709

  • Electronystagmograph
  • Dynamic visual acuity testing system
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution

  • B516222210 ()
22221

  • Electronystagmograph
  • Dynamic visual acuity testing system
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. HEADSTAR is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus), the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests and the Video Head Impulse Test. HEADSTAR is a nystagmography system and is able to record movements of one eye: horizontal, vertical and rotary on option. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. HEADSTAR is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run VHIT tests and other oculomotor tests.
Instrumentation Difra SA
HeadStar
In Commercial Distribution

  • B516221350 ()
22135

  • Electronystagmograph
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin.
Instrumentation Difra SA
NysStar II
In Commercial Distribution

  • B516221340 ()
22134

  • Electronystagmograph
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR I is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests). NYSSTAR I is able to record all eye movements, as well horizontal, as vertical and even rotary movements on option. The calibration carried out by NYSSTAR I is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin.
Instrumentation Difra SA
NysStar I
In Commercial Distribution

  • B516221280 ()
22128

  • Electronystagmograph
The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
EKSO BIONICS, INC.
GT
In Commercial Distribution

  • B1431200000 ()


  • Programmable ambulation exoskeleton, clinical
EKSO BIONICS SYSTEM, Ekso NR
EKSO BIONICS, INC.
EKSONR
In Commercial Distribution

  • B168EKSONR0 ()
EKSONR

  • Programmable ambulation exoskeleton, clinical
EKSO BIONICS SYSTEM, Ekso GT
EKSO BIONICS, INC.
EKSOGT
In Commercial Distribution

  • B168EKSOGT0 ()
EKSOGT

  • Programmable ambulation exoskeleton, clinical
Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.
EKSO BIONICS, INC.
501-110-001
In Commercial Distribution

  • M704501110001 ()


  • Programmable ambulation exoskeleton, clinical
Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
EKSO BIONICS, INC.
501-100-000
In Commercial Distribution

  • M704501100000 ()


  • Programmable ambulation exoskeleton, clinical
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