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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No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219257 ()
  • 06942135219251 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219240 ()
  • 06942135219244 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
No Description
United Dental Changzhou
V2
In Commercial Distribution

  • 86942135219233 ()
  • 06942135219237 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
Mobile application used by patients for disease management
Takeda Pharmaceuticals U.S.A., Inc.
V2
In Commercial Distribution

  • 00850025688826 ()


  • Home pharmaceutical management support software
No Description
Munevo Inc.
V2
In Commercial Distribution

  • 04260691380010 ()


  • Wheelchair steering/control unit
No Description
aycan Digitalsysteme GmbH
v2
In Commercial Distribution

  • 04260476510045 ()


  • Radiology picture archiving and communication system workstation
MAXIO V2 is a stereotactic accessory intended for the spatial positioning and orientation of an instrument guide to assist in manual advancement of one or more instruments for image guided procedures. It provides Preoperative planning and intra operative guidance to the surgeon by visually representing the targeted path and position(s) on the image based model of the target organ along with the data provided by the instrument manufacturer.
PERFINT HEALTHCARE PRIVATE LIMITED
V2
In Commercial Distribution

  • 08908002051063 ()


  • Robotic surgical navigation system
Main Unit;
CNSystems Medizintechnik GmbH
V2
In Commercial Distribution

  • 09120073932150 ()
FHTF3049

  • General-purpose multi-parameter bedside monitor
Main Unit;
CNSystems Medizintechnik AG
V2
Not in Commercial Distribution

  • 09120073930644 ()
00361

  • Noninvasive haemodynamic monitoring system
Type 3040i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP) 09120073930446, ECG cable, 2.5m, ECG cable with protection against defibrillation, "double nose" connector 09120073930507, ICG cable, 2.5m, ICG cable with protection against defibrillation, "double nose" connector 09120073930460; 20pcs., Set of electrodes; Set include 4ECG electrodes, 3 ICG electrodes and one grounding pad 09120073930538, Flying-V - finger cuff (large) 09120073930545, Flying-V - finger cuff (medium) 09120073930552, Flying-V - finger cuff (small) 09120073930521, 2.5m, Air hose incl. 2x Rectus connector 09120073930562, Flying-V Forearm fixing cuff, for Vascular Unloading device (arm fixation cuff contBP module) NBP cuffs: 10840935102250, Cuff, AllPurpose, General, Large Adult, 98-0099-19, 30-FEMA-15450 10840935102182, Cuff, AllPurpose, General, Adult, 98-0097-30, 30-FEMA-15350 040437180041338, IEEE 1394 (FireWire) cable, 6/6 pin, 1,8m Electric supply wire, 3m,Interpower, grounded plug 09120073930590, Instruction manual English USA 04046938268248, Arm sling
CNSystems Medizintechnik AG
V2
Not in Commercial Distribution

  • 09120073930637 ()
03141

  • Noninvasive haemodynamic monitoring system
Main Unit;
CNSystems Medizintechnik GmbH
V2
Not in Commercial Distribution

  • 09120073931924 ()
FHTF3141

  • General-purpose multi-parameter bedside monitor
Type 3030i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP) 09120073930446, ECG cable, 2.5m, ECG cable with protection against defibrillation, "double nose" connector 09120073930538, Flying-V - finger cuff (large) 09120073930545, Flying-V - finger cuff (medium) 09120073930552, Flying-V - finger cuff (small) 09120073930521, 2.5m, Air hose incl. 2x Rectus connector 09120073930562, Flying-V Forearm fixing cuff, for Vascular Unloading device (arm fixation cuff contBP module) NBP cuffs: 10840935102182, 10840935102250, Cuff, AllPurpose, General, Large Adult, 98-0099-19, 30-FEMA-15450 Cuff, AllPurpose, General, Adult, 98-0097-30, 30-FEMA-15350 040437180041338, IEEE 1394 (FireWire) cable, 6/6 pin, 1,8m Electric supply wire, 3m,Interpower, grounded plug 09120073930590, Instruction manual English USA 04046938268248, Arm sling
CNSystems Medizintechnik AG
V2
Not in Commercial Distribution

  • 09120073930804 ()
03038

  • Noninvasive haemodynamic monitoring system
Type 3040i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP) 09120073930446, ECG cable, 2.5m, ECG cable with protection against defibrillation, "double nose" connector 09120073930507, ICG cable, 2.5m, ICG cable with protection against defibrillation, "double nose" connector 09120073930460; 20pcs., Set of electrodes; Set include 4ECG electrodes, 3 ICG electrodes and one grounding pad 09120073930675, Flying-V - finger cuff (large) 09120073930682, Flying-V - finger cuff (medium) 09120073930699, Flying-V - finger cuff (small) 09120073930521, 2.5m, Air hose incl. 2x Rectus connector 09120073930562, Flying-V Forearm fixing cuff, for Vascular Unloading device (arm fixation cuff contBP module) NBP cuffs: 10840935102250, Cuff, AllPurpose, General, Large Adult, 98-0099-19, 30-FEMA-15450 10840935102182, Cuff, AllPurpose, General, Adult, 98-0097-30, 30-FEMA-15350 040437180041338, IEEE 1394 (FireWire) cable, 6/6 pin, 1,8m Electric supply wire, 3m,Interpower, grounded plug 09120073930590, Instruction manual English USA 04046938268248, Arm sling
CNSystems Medizintechnik AG
V2
Not in Commercial Distribution

  • 09120073930712 ()
03141

  • Noninvasive haemodynamic monitoring system
Type 3030i , SET of: 09120073930644, TASK FORCE® MONITOR, Main Unit (incl. ContBP) 09120073930446, ECG cable, 2.5m, ECG cable with protection against defibrillation, "double nose" connector 09120073930675, Flying-V - finger cuff (large) 09120073930682, Flying-V - finger cuff (medium) 09120073930699, Flying-V - finger cuff (small) 09120073930521, 2.5m, Air hose incl. 2x Rectus connector 09120073930562, Flying-V Forearm fixing cuff, for Vascular Unloading device (arm fixation cuff contBP module) NBP cuffs: 10840935102182, 10840935102250, Cuff, AllPurpose, General, Large Adult, 98-0099-19, 30-FEMA-15450 Cuff, AllPurpose, General, Adult, 98-0097-30, 30-FEMA-15350 040437180041338, IEEE 1394 (FireWire) cable, 6/6 pin, 1,8m Electric supply wire, 3m,Interpower, grounded plug 09120073930590, Instruction manual English USA 04046938268248, Arm sling
CNSystems Medizintechnik AG
V2
Not in Commercial Distribution

  • 09120073930705 ()
03038

  • Noninvasive haemodynamic monitoring system
No Description
QIAGEN GmbH
V2
In Commercial Distribution

  • 04053228043249 ()
691421

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Accessory to Cube navigation systems. Device for registration.
Fiagon GmbH
v2
Not in Commercial Distribution

  • EFIAE0114301 ()
E 01 1430

  • ENT stereotactic surgery system
No Description
GE Medical Systems (China) Co.,Ltd.
V2
In Commercial Distribution

  • 00840682102933 ()


  • General-purpose ultrasound imaging system
The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment. The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen. In particular, the device is intended to provide: Linear distance measurements of anatomical structures, Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen, Estimates of ultrasound tissue brightness parameters in the liver at selected ultrasound frequencies, Measurement of brightness ratio between structures and in particular between the liver and the kidney, Estimates of speed of sound in the liver. The shear wave speed measurements, ultrasound tissue brightness parameters, elastic properties estimates, brightness ratio may be used as an aid to the diagnosis, monitoring and clinical management of adult and pediatric patients with liver disease.
E-SCOPICS
V2
In Commercial Distribution

  • 03770023859011 ()


  • Ultrasound imaging system application software
  • Hepatic ultrasound elastography system
Device is a charging and transportation case for up to 12 pair of FTM-DK insoles
FEETME
V2
In Commercial Distribution

  • 03760349820116 ()


  • Noninvasive device battery charger
No Description
FIM MEDICAL
V2
In Commercial Distribution

  • 03760253450294 ()


  • Carbon monoxide breath analyser
No Description
NOTAL VISION LTD
V2
In Commercial Distribution

  • 07290017803005 ()
901F001

  • Macular pigment analyser
Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyze and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters, including left/ right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Us2.v2 is indicated for use in adult patients. Please note the following limitations: • Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. • Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. • If no gender is present, female referenced guideline values will be used for conclusions. • If Body Surface Area (BSA) is not present, indexed values cannot be provided. • During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.
EKO.AI PTE. LTD.
2
In Commercial Distribution

  • 00860005876815 ()


  • Radiology DICOM image processing application software
The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data. The device is intended for use on users who are 18 years of age or older. The device does not output heart rate or respiratory rate measurements during periods of motion or activity. The device is not intended for use on critical care patients.
BIOINTELLISENSE, INC.
BIOST05020F
In Commercial Distribution

  • 10850005949142 ()
  • 00850005949145 ()
SKU# B2-ST05-02-0-00-GY

  • Wearable multiple physiological parameter recorder, reusable
OptimMRI is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. The software can be used to process pre-operative DICOM compatible MR images to generate 3D annotated models of the brain that aid the user in neurosurgical functional planning. The annotated MR images can further be used in conjunction with other clinical methods as an aid in localization of the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) regions of interest.
REBRAIN
v2.0.1
In Commercial Distribution

  • 03770021895035 ()


  • Stereotactic system application software
Reusable Extension Cable
Oscor Inc.
ATAR-V2
Not in Commercial Distribution

  • 00885672102715 ()

  • Length: 250 Centimeter
ATAR-V2

  • Pacing/defibrillation lead electrical adaptor
ClearPoint v2.x Neuro Workstation
Clearpoint Neuro, Inc.
CP-WRK-03
In Commercial Distribution

  • 00850359007539 ()
CP-WRK-03

  • Neurological stereotactic surgery system
MammoRx® Bottom Stop (V2)
Orfit Industries NV
CBS-2
In Commercial Distribution

  • 05420028709931 ()


  • Radiological whole-body positioner
MNA-420 DEC HDMI V2 IN
Barco NV
MNA-420
In Commercial Distribution

  • 05415334037625 ()
k9303331D

  • Operating room audiovisual data/device management system
NEXXIS SYSTEM X620 CM V2
Barco NV
Nexxis
In Commercial Distribution

  • 05415334030220 ()


  • Operating room audiovisual data/device management system
NEXXIS SYSTEM X670 CM V2
Barco NV
Nexxis
In Commercial Distribution

  • 05415334030213 ()


  • Operating room audiovisual data/device management system
MNA-420 DEC HDMI V2 UK
Barco NV
MNA-420 DEC
In Commercial Distribution

  • 05415334027329 ()
K9303331G

  • Operating room audiovisual data/device management system
MNA-240 DEC V2 INC SFP+
Barco NV
MNA-240 DEC
In Commercial Distribution

  • 05415334025011 ()
K9303275a

  • Operating room audiovisual data/device management system
ORT200 Covered Table Assembly V2
IMRIS Imaging, Inc.
113821-000
In Commercial Distribution

  • 00857534006738 ()


  • Basic diagnostic x-ray system table, powered
ACC. ME IRIC CHARGER V2
Ws Audiology Usa, Inc.
MECHARGE iRIC Charger v2
In Commercial Distribution

  • 05714880161472 ()
21014782

  • Noninvasive device battery charger
HEADGEAR CLIPS PKG V2 HEADGEAR
HANS RUDOLPH, INC.
7450
In Commercial Distribution

  • 00874750004010 ()
201555

  • Pulmonary function valve
RETRACTOR HOLDER 9734119 HEADHOLDER V2
MEDTRONIC NAVIGATION, INC.
9734119
In Commercial Distribution

  • 00613994575463 ()


  • Extremity MRI system, permanent magnet
UTK MODULE V2 ASSY - 2
WELCH ALLYN, INC.
901078
Not in Commercial Distribution

  • 00732094318388 ()
26025-092-404

  • Electrocardiograph, professional, multichannel
WADCS ECG SOFTWARE V2.X
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315493 ()
729324

  • Electrocardiograph, professional, multichannel
WADCS SPIRO SOFTWARE V2.X
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315486 ()
729325

  • Electrocardiograph, professional, multichannel
WADCS MANAGER SOFTWARE V2.X
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315479 ()
729326

  • Electrocardiograph, professional, multichannel
v2 Facemask- DP Dermaceuticals Branded
I-SMART DEVELOPMENTS LIMITED
TN19G
In Commercial Distribution

  • 05060534510104 ()
111B

  • Cosmetic red-light phototherapy system, home-use
User's Manual, LiDCOrapid, V2, English
LIDCO LIMITED
HM 81-02 UM-044
In Commercial Distribution

  • 05060110521548 ()
HM 81-02 UM-044

  • General-purpose multi-parameter bedside monitor
Kit, Head Mounted Device, V2
POLARISAR, INC.
Revision 01
In Commercial Distribution

  • 00850046497148 ()
80-0007

  • Orthopaedic stereotactic surgery system
Apnea Guard Device High (V2)
ADVANCED BRAIN MONITORING, INC.
25-1003
In Commercial Distribution

  • 00850015266027 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Apnea Guard Device Medium (V2)
ADVANCED BRAIN MONITORING, INC.
25-1002
In Commercial Distribution

  • 00850015266010 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Apnea Guard Device Low (V2)
ADVANCED BRAIN MONITORING, INC.
25-1001
In Commercial Distribution

  • 00850015266003 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
MAF v2 Probe Red (ASR)
CYTOCELL LIMITED
LPH567-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
MAF v2 in Aqua Spectrum
CYTOCELL LIMITED
MPD22713
In Commercial Distribution

  • 05055844909250 ()


  • Assay development analyte-specific reagent IVD
11cen in Aqua Spectrum v2
CYTOCELL LIMITED
MPD20993
In Commercial Distribution

  • 05055844909205 ()


  • Assay development analyte-specific reagent IVD
11q23 in FITC Spectrum v2
CYTOCELL LIMITED
MPD20992
In Commercial Distribution

  • 05055844909199 ()


  • Assay development analyte-specific reagent IVD
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