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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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iFusion - 00858848006629

iVue NR for iFusion 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006629 ()
700-49000-005

  • Ophthalmic spectral-domain optical coherence tomography system
  • Ophthalmic fundus camera

iFusion - 00858848006308

iVue NR for iFusion USCFG System w/ 230V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006308 ()
700-48586-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system

iFusion - 00858848006292

iVue NR for iFusion System w/ 230V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006292 ()
700-48585-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system

iFusion - 00858848006247

iVue NR for iFusion USCFG System w/ 120V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006247 ()
700-48371-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system

iFusion - 00858848006230

iVue NR for iFusion System w/ 120V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006230 ()
700-48363-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system

iFusion - 00858848006209

iVue NR for iFusion USCFG 230V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006209 ()
700-49003-004

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system

iFusion - 00858848006193

iVue NR for iFusion 230V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006193 ()
700-49002-004

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system

iFusion - 00858848006186

iVue NR for iFusion USCFG 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006186 ()
700-49001-004

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system

iFusion - 00858848006179

iVue NR for iFusion 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006179 ()
700-49000-004

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system

Pathway - 00852423006011

Pathway® CTS 2000
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS2000
In Commercial Distribution

  • 00852423006011 ()
CTS2000

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional

Pathway - 00852423006028

Pathway® CTS 1500
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS1500
In Commercial Distribution

  • 00852423006028 ()
CTS1500

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional

Tracey-VFA Visual Function Analyzer - 00860479001706

The iTrace is used to measure the refractive, wavefront and corneal topographic data of the human optical system.
TRACEY TECHNOLOGIES, CORPORATION
iTrace
In Commercial Distribution

  • 00860479001706 ()
Z2000

  • Corneal topography system
  • Automated ophthalmic refractometer

RETIA 2 - 08053677040086

The CenterVue Retia 2 Camera is intended for taking digital autofluorescence images of the human retina with and without use of a mydriatic agent to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.
CENTERVUE SPA
RETIA 2
In Commercial Distribution

  • 08053677040086 ()
AINEUME002

  • Ophthalmic fundus camera
  • Scanning-laser retinal imaging system

CIRRUS photo - 04049471096026

The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and nonmydriatic conditions. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in-vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula and optic disc. It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. The CIRRUS photo is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma.
Carl Zeiss Meditec AG
CIRRUS photo 800
In Commercial Distribution

  • 04049471096026 ()

  • Weight: 33 Kilogram
  • Total height (including head rest) 1390 mm (plus 300 mm lift)
  • Footprint of table-top unit 469 mm x 466 mm (including lateral cable covers)
  • Utility space of instrument table (W x D) 1060 mm x 420 mm


  • Ophthalmic spectral-domain optical coherence tomography system
  • Ophthalmic fundus camera

CIRRUS photo - 04049471096019

The CIRRUS photo is a non-contact, high-resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and nonmydriatic conditions. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in-vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, macula and optic disc. It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. The CIRRUS photo is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma.
Carl Zeiss Meditec AG
CIRRUS photo 600
In Commercial Distribution

  • 04049471096019 ()

  • Weight: 33 Kilogram
  • Total height (including head rest) 1390 mm (plus 300 mm lift)
  • Footprint of table-top unit 469 mm x 466 mm (including lateral cable covers)
  • Utility space of instrument table (W x D) 1060 mm x 420 mm


  • Ophthalmic spectral-domain optical coherence tomography system
  • Ophthalmic fundus camera

Em Disposable Stylet - 04056481006525

No Description
Brainlab AG
18097
In Commercial Distribution

  • 04056481004958 ()
  • 04056481006525 ()
  • 04056481004965 ()
18097

  • Robotic surgical navigation system
  • Intracranial catheter navigation transmitter stylet

Waya Rehab - G741WHREHABV10

Waya® Rehab is a software only medical device to support rehabilitation under the guidance of a qualified healthcare professional.
WELLOVATE, LLC
1
In Commercial Distribution

  • G741WHREHABV10 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software

ZEISS - 03664188000589

No Description
LUNEAU TECHNOLOGY OPERATIONS
VISUREF 1000
In Commercial Distribution

  • 03664188000589 ()


  • Multiple ocular dimension meter
  • Ophthalmic fundus camera

RODENSTOCK - 03664188000404

No Description
LUNEAU TECHNOLOGY OPERATIONS
DNEye Scanner 3
In Commercial Distribution

  • 03664188000404 ()


  • Multiple ocular dimension meter
  • Ophthalmic fundus camera

VRPhysio - 07290016986099

A software-only medical device intended for cervical region rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The N-140 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. N-140 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
N-140 (Rotate)
In Commercial Distribution

  • 07290016986099 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software

VRPhysio - 07290016986082

A software-only medical device intended for upper extremity and full body rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of physical exercises according to their treating medical practitioner's guidelines. The MT-220 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. MT-220 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
MT-220 (Balloon Blast)
In Commercial Distribution

  • 07290016986082 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software

VRCogni - 07290016986075

A software-only medical device intended for motor-cognitive rehabilitation. The software tracks motion and movement kinematics and guides patients in the performance of motor-cognitive exercises according to their treating medical practitioner's guidelines. The MC-320 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. MC-320 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.
XR HEALTH IL LTD
MC-320 (Color Match)
In Commercial Distribution

  • 07290016986075 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software

RPM2 Rx - 00850023296344

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (3)
Not in Commercial Distribution

  • 00850023296344 ()
Shoe insole size 3 (women 13.0 to 15.0) (men 11.0 to 12.50)

  • Pressure monitoring insole

RPM2 Rx - 00850023296320

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (2)
Not in Commercial Distribution

  • 00850023296320 ()
Shoe insole size 2 (women 11.0 to 12.5) (men 9.0 to 10.5)

  • Pressure monitoring insole

RPM2 Rx - 00850023296313

footbed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (12)
Not in Commercial Distribution

  • 00850023296313 ()
Shoe insole size (12) (women 9.0 to 10.5) (men 7.0 to 8.5)

  • Pressure monitoring insole

RPM2 Rx - 00850023296290

footbed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (01)
Not in Commercial Distribution

  • 00850023296290 ()
Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to 8.5)

  • Pressure monitoring insole

RPM2 Rx - 00850023296283

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (00)
Not in Commercial Distribution

  • 00850023296283 ()
Shoe insole size 00 (women 3.0 to 6.5)

  • Pressure monitoring insole

RPM2 Rx - 00850023296276

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (0)
Not in Commercial Distribution

  • 00850023296276 ()
Shoe insole size 0 (women 7.0 to 8.5) (men 5.0 to 6.5)

  • Pressure monitoring insole

STEPRITE - 00850023296160

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (3)
In Commercial Distribution

  • 00850023296160 ()
Shoe insole size 3 (women 13.0 to 15.0) (men 11.0 to 12.50)

  • Pressure monitoring insole

STEPRITE - 00850023296085

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (4)
In Commercial Distribution

  • 00850023296085 ()
Shoe insole size 4 (men 13.0 to 15.0)

  • Pressure monitoring insole

RPM2 Rx - 00850023296351

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (4)
Not in Commercial Distribution

  • 00850023296351 ()
Shoe insole size 4 (men 13.0 to 15.0)

  • Pressure monitoring insole

RPM2 Rx - 00850023296337

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (2-3)
Not in Commercial Distribution

  • 00850023296337 ()
Shoe insole size (2-3) (women 11.0 to 12.5) (men 9.0 to 10.5)

  • Pressure monitoring insole

RMP2 Rx - 00850023296306

footbed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (1)
Not in Commercial Distribution

  • 00850023296306 ()
Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to 8.5)

  • Pressure monitoring insole

STEPRITE - 00850023296061

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (2)
In Commercial Distribution

  • 00850023296061 ()
Shoe insole size 2 (women 11.0 to 12.5) (men 9.0 to 10.5)

  • Pressure monitoring insole

STEPRITE - 00850023296054

footbed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (1)
In Commercial Distribution

  • 00850023296054 ()
Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to 8.5)

  • Pressure monitoring insole

STEPRITE - 00850023296047

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (0)
In Commercial Distribution

  • 00850023296047 ()
Shoe insole size 0 (women 7.0 to 8.5) (men 5.0 to 6.5)

  • Pressure monitoring insole

STEPRITE - 00850023296030

Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (00)
In Commercial Distribution

  • 00850023296030 ()
Shoe insole size 00 (women 3.0 to 6.5)

  • Pressure monitoring insole

32" x 24" Adaptive Desk - 00850001752473

Adaptive classroom desk
RIFTON EQUIPMENT
R240
In Commercial Distribution

  • 00850001752473 ()


  • Ergonomic workdesk, manual

Adaptive Desk - 00850001752428

Adaptive classroom desk
RIFTON EQUIPMENT
R250
In Commercial Distribution

  • 00850001752428 ()


  • Ergonomic workdesk, manual

Canaview - 00628504370056

Intra Oral Camera, Direct-USB, Auto-Focus
Beyes Dental Canada Inc
EV2060
In Commercial Distribution

  • 00628504370056 ()


  • Intraoral camera

KOWA FM-600 - 04987646804024

KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.
KOWA COMPANY,LTD.
LSS50BK
In Commercial Distribution

  • 04987646804024 ()

  • Height: 458 Millimeter
  • Depth: 457 Millimeter
  • Width: 274 Millimeter
  • Weight: 18 Kilogram


  • Aqueous flare/cell measuring system

Etymotic Research, Inc. - 00846430004009

Changing tool with filters(orange) HHT
ETYMOTIC RESEARCH, INC.
ER38-46HHT
In Commercial Distribution

  • 00846430004009 ()
  • 00846430004856 ()


  • Tone audiometer

N/A - 00846430004634

Striped Red Tubing 100pk
ETYMOTIC RESEARCH, INC.
ER3-21TR
In Commercial Distribution

  • 00846430004634 ()
  • 00846430004887 ()


  • Tone audiometer

Etymotic Research, Inc. - 00846430004023

Home Hearing Test
ETYMOTIC RESEARCH, INC.
ER120 HHT
In Commercial Distribution

  • 00846430004023 ()


  • Tone audiometer

Etymotic - 00846430004016

Replacement Filters 6pk-orange
ETYMOTIC RESEARCH, INC.
ER38-50HT
In Commercial Distribution

  • 00846430004016 ()
  • 00846430004856 ()


  • Tone audiometer

hearX - 00860003469811

No Description
HEARX GROUP (PTY) LTD
hearTest
In Commercial Distribution

  • 00860003469811 ()


  • Tone audiometer

Swoop Site Quality Assurance Phantom - 00860000606134

The Site Quality Assurance Phantom is specifically designed as a medical device and augments the scanner by allowing weekly quality control checks of the functioning of the scanner in the hospital environment.
Hyperfine Operations, Inc.
V1.0 (810-11049-01)
In Commercial Distribution

  • 00860000606134 ()


  • MRI phantom, test object

Salux™ - 00860007826634

Salux™ Tablet-Controlled Bluetooth Audiometer - The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux Audiometric solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-AU-02
In Commercial Distribution

SALUX-AU-02

  • Tone audiometer

Parallel(TM) - 00860006172008

ParallelTM is a Prescription Digital Therapeutic (PDT) web application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS).
Mahana Therapeutics, Inc.
01-0001-001
In Commercial Distribution

  • 00860006172008 ()
01-0001-001

  • Mindfulness/behavioural therapy software, non-clinician-consultative

Regulora® - 00860005970209

Regulora® is prescription-only digital therapeutic (PDT) software indicated for use in the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS). The Regulora program is Software as a Medical Device (SaMD) that resides on and is accessed through the user’s mobile device and can be executed at home. Regulora digitizes scripted therapist-administered gut-directed psychotherapy and provides 7 unique treatment sessions, each lasting ~30 minutes, every other week over 12 weeks. The treatment sessions are designed to first induce deep physical and autonomic relaxation which is followed by metaphorical storytelling and a combination of direct and indirect suggestions targeted at somatic control mechanisms. Regulora also provides for IBS symptom tracking, which patients can share with their doctor in the management of their IBS.
Metame Health, Inc.
GDH-1
In Commercial Distribution

  • 00860005970209 ()
60005-97020

  • Mindfulness/behavioural therapy software, non-clinician-consultative
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