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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LOGIQ e TB Standard Console
GE Medical Systems (China) Co.,Ltd.
e TB
In Commercial Distribution

  • 00195278674203 ()


  • General-purpose ultrasound imaging system
LOGIQ e TP Standard Console
GE Medical Systems (China) Co.,Ltd.
e TP
In Commercial Distribution

  • 00195278674197 ()


  • General-purpose ultrasound imaging system
Senographe Pristina 3D UDI
GE MEDICAL SYSTEMS
NAY3
In Commercial Distribution

  • 00195278665379 ()


  • Stationary mammographic x-ray system, digital
LOGIQ Totus
GE Ultrasound Korea Ltd.
Totus
In Commercial Distribution

  • 00195278664600 ()
5926013

  • General-purpose ultrasound imaging system
Senographe Pristina 2D UDI
GE MEDICAL SYSTEMS
NAY2
In Commercial Distribution

  • 00195278661999 ()


  • Stationary mammographic x-ray system, digital
Vscan Air SL
GE Vingmed Ultrasound AS
Air SL
In Commercial Distribution

  • 00195278660701 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
RAB7-D
GE Medical Systems (China) Co.,Ltd.
RAB7-D
In Commercial Distribution

  • 00195278644152 ()
H48062AN

  • Extracorporeal ultrasound imaging transducer, hand-held
VOLUSON SIGNATURE 18
GE Ultrasound Korea Ltd.
Signature 18
In Commercial Distribution

  • 00195278633811 ()
Voluson-Signature-18

  • General-purpose ultrasound imaging system
VOLUSON SIGNATURE 20
GE Ultrasound Korea Ltd.
Signature 20
In Commercial Distribution

  • 00195278633804 ()
Voluson-Signature-20

  • General-purpose ultrasound imaging system
Portrait VSM ATO MODEL
Ge Medical Systems Information Technologies, Inc.
MVC101
In Commercial Distribution

  • 00195278561312 ()
6660000-666

  • Multiple vital physiological parameter monitoring system, clinical
Voluson SWIFT+ BT23
GE Ultrasound Korea Ltd.
SWIFT+ BT23
In Commercial Distribution

  • 00195278560155 ()
5919111

  • General-purpose ultrasound imaging system
Voluson SWIFT BT23
GE Ultrasound Korea Ltd.
SWIFT
In Commercial Distribution

  • 00195278560148 ()
5919109

  • General-purpose ultrasound imaging system
Vivid iq v203 to v206 upgrade kit
GE Medical Systems (China) Co.,Ltd.
iq v203 to v206 UPG
In Commercial Distribution

  • 00195278530981 ()


  • Cardiovascular ultrasound imaging system
SLIDING 19X23 PADDLE - labelled
GE MEDICAL SYSTEMS
19X23SLD
In Commercial Distribution

  • 00195278527950 ()


  • Stationary mammographic x-ray system, digital
Sliding 2D Loc 19X23 paddle - Labelled
GE MEDICAL SYSTEMS
SLD 2D
In Commercial Distribution

  • 00195278527943 ()


  • Stationary mammographic x-ray system, digital
Sliding round spot paddle - Labelled
GE MEDICAL SYSTEMS
SLD RND
In Commercial Distribution

  • 00195278527936 ()


  • Stationary mammographic x-ray system, digital
Sliding 10x23 Implant Paddle - Labelled
GE MEDICAL SYSTEMS
SLD IMP
In Commercial Distribution

  • 00195278527929 ()


  • Stationary mammographic x-ray system, digital
24x29 FLEXIBLE PADDLE - Labelled
GE MEDICAL SYSTEMS
24x29 FLEX
In Commercial Distribution

  • 00195278527912 ()


  • Stationary mammographic x-ray system, digital
Sliding square spot paddle - Labelled
GE MEDICAL SYSTEMS
SLD SQR
In Commercial Distribution

  • 00195278527905 ()


  • Stationary mammographic x-ray system, digital
Sliding 2D Loc 19x23 Perforated Paddle- Labelled
GE MEDICAL SYSTEMS
SLD 2D PF
In Commercial Distribution

  • 00195278527899 ()


  • Stationary mammographic x-ray system, digital
24x29 STANDARD PADDLE - labelled
GE MEDICAL SYSTEMS
24x29 STD
In Commercial Distribution

  • 00195278527882 ()


  • Stationary mammographic x-ray system, digital
F2 FRAME BASIC UNIT HLA
GE Healthcare Finland Oy
F2-01
In Commercial Distribution

  • 00195278524089 ()
5861293

  • Patient monitoring system module rack
CARESCAPE Canvas D19
GE Healthcare Finland Oy
5897061
In Commercial Distribution

  • 00195278523365 ()
5897061

  • Image display unit, colour
CARESCAPE CANVAS 1000
GE Healthcare Finland Oy
5876727
In Commercial Distribution

  • 00195278522320 ()
5876727

  • General-purpose multi-parameter bedside monitor
CARESCAPE Canvas Smart Display
GE Healthcare Finland Oy
5897060
In Commercial Distribution

  • 00195278522313 ()
5897060

  • General-purpose multi-parameter bedside monitor
Venue Go R4 Final Assembly
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
R4
In Commercial Distribution

  • 00195278516510 ()


  • General-purpose ultrasound imaging system
Venue Fit R4 Final Assembly
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
R4
In Commercial Distribution

  • 00195278516497 ()


  • General-purpose ultrasound imaging system
Venue R4 final Assembly
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
R4
In Commercial Distribution

  • 00195278516480 ()


  • General-purpose ultrasound imaging system
Vivid E90 v206
GE Vingmed Ultrasound AS
E90 v206
In Commercial Distribution

  • 00195278505354 ()


  • Cardiovascular ultrasound imaging system
Vivid E95 v206
GE Vingmed Ultrasound AS
E95 v206
In Commercial Distribution

  • 00195278505330 ()


  • Cardiovascular ultrasound imaging system
Vivid S60N v206 NOR
GE Vingmed Ultrasound AS
S60N v206
In Commercial Distribution

  • 00195278505316 ()


  • Cardiovascular ultrasound imaging system
Vivid S70N v206 NOR
GE Vingmed Ultrasound AS
S70N v206
In Commercial Distribution

  • 00195278505255 ()


  • Cardiovascular ultrasound imaging system
Vivid S60N v206 China
GE Vingmed Ultrasound AS
S60N v206CH
In Commercial Distribution

  • 00195278505187 ()


  • Cardiovascular ultrasound imaging system
Vivid S70N v206 China
GE Vingmed Ultrasound AS
S70N v206CH
In Commercial Distribution

  • 00195278505170 ()


  • Cardiovascular ultrasound imaging system
Versana Essiential R2 VA
GE Medical Systems (China) Co.,Ltd.
Essential R2 VA
In Commercial Distribution

  • 00195278503411 ()


  • General-purpose ultrasound imaging system
Versana Essential R2 VS
GE Medical Systems (China) Co.,Ltd.
Essential R2 VS
In Commercial Distribution

  • 00195278503404 ()


  • General-purpose ultrasound imaging system
Vivid iq V204 to V206 SW only upgrade kit
GE Medical Systems (China) Co.,Ltd.
iq v204 to v206 UPG SW only
In Commercial Distribution

  • 00195278488527 ()


  • Cardiovascular ultrasound imaging system
The Insight Infrared Video Goggles Pro+ are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.
Vestibular First, LLC
Insight Infrared Video Goggles Pro+
In Commercial Distribution

  • 10860002280742 ()
  • 00860002280745 ()
INSIGHT-PRO-PLUS

  • Eye/eyelid movement monitoring spectacles/goggles
The Insight Infrared Video Goggles Pro are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.
Vestibular First, LLC
Insight Infrared Video Goggles Pro
In Commercial Distribution

  • 10860002280735 ()
  • 00860002280738 ()
INSIGHT-VIDEO-GOGGLES-PRO

  • Eye/eyelid movement monitoring spectacles/goggles
The disposable cushion for the Insight series of Video Goggles are designed for settings where infection control is top priority. The cushions are easy to replace with simple hook and loop connection, comfortable for patients, and have excellent light-blocking properties. Cushions are one-time use and are not reusable. This box contains 40 cushions.
Vestibular First, LLC
Insight Disposable Cushions - 40-Count
In Commercial Distribution

  • 00860002280714 ()
PART-DISPOSABLE-CUSHION-40CT

  • Eye/eyelid movement monitoring spectacles/goggles
The Insight Infrared Video Goggles are designed to be used by clinicians to visualize and record patient eye movements. The goggles will be placed on the patient’s head with the cameras in front of the patient’s eyes. The infrared cameras transmit video of the eye movements to a compatible computer screen for display. The computer uses an off-the-shelf video software Open Broadcaster Software (OBS) to allow viewing and recording of the cameras.
Vestibular First, LLC
Insight Infrared Video Goggles
In Commercial Distribution

  • 10860002280704 ()
  • 00860002280707 ()


  • Vision/eye movement analysis system
The Light Jacket® Attachable Light for Electrosurgical Pencil is offered as a sterile, one-time use disposable medical device for providing enhanced illumination of the surgical site when attached to an electrosurgical pencil.
PATHY MEDICAL, LLC
PM-LJ100
In Commercial Distribution

  • 00860000230704 ()
  • 00860000230711 ()


  • Operating room light
VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.
VIVALNK, INC.
VV350
In Commercial Distribution

  • 00860008259233 ()


  • Electrocardiography telemetric monitoring system
The CarePath system facilitates evaluations measuring urine output. It consists of the CarePath device, accompanying documents, and training. The system: • Measures and calculates flow rate and volume from urination data • Automatically transmits urination data to a secure location • Creates and provides uroflow reports to healthcare providers The intended operator of the CarePath device is the patient. The CarePath system has no user-serviceable components. This system is not to be serviced or maintained by the user. The intended environments are hospitals, clinics, doctor’s offices and the patient’s home.
I/O Urology Corp.
DCDUFD-001M
In Commercial Distribution

  • 00860010862209 ()


  • Urine flowmeter, reusable
Neuromuscular transmission (NMT) monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.
NERBIO PRIVATE LIMITED
ITOFDEV01
In Commercial Distribution

  • 00860012119660 ()
  • 00860012119677 ()


  • Block-monitoring peripheral nerve electrical stimulation system
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-128015
In Commercial Distribution

  • 06939698601494 ()
PBCS-128015

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-128014
In Commercial Distribution

  • 06939698601487 ()
PBCS-128014

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-128013
In Commercial Distribution

  • 06939698601470 ()
PBCS-128013

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-125015
In Commercial Distribution

  • 06939698601463 ()
PBCS-125015

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-125014
In Commercial Distribution

  • 06939698601456 ()
PBCS-125014

  • Neural-tissue balloon catheter
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