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

Show Filters

0.35mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-035-010-PL
In Commercial Distribution

  • EIBAVC035010PL0 ()
VC-035-010-PL

  • Radiological image marker, implantable
0.35mm x 0.5cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
VC-035-005-PL
In Commercial Distribution

  • EIBAVC035005PL0 ()
VC-035-005-PL

  • Radiological image marker, implantable
0.35mm x 3.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle.
Izi Medical Products, LLC
SNMR-035-030-2220
In Commercial Distribution

  • EIBASNMR03503022200 ()
SNMR-035-030-2220

  • Radiological image marker, implantable
0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle.
Izi Medical Products, LLC
SNMR-035-020-2220
In Commercial Distribution

  • EIBASNMR03502022200 ()
SNMR-035-020-2220

  • Radiological image marker, implantable
0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SNMR-035-020-2215
In Commercial Distribution

  • EIBASNMR03502022150 ()
SNMR-035-020-2215

  • Radiological image marker, implantable
0.35mm x 2.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle.
Izi Medical Products, LLC
SNMR-035-020-2208
In Commercial Distribution

  • EIBASNMR03502022080 ()
SNMR-035-020-2208

  • Radiological image marker, implantable
0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle.
Izi Medical Products, LLC
SNMR-035-010-2220
In Commercial Distribution

  • EIBASNMR03501022200 ()
SNMR-035-010-2220

  • Radiological image marker, implantable
0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SNMR-035-010-2215
In Commercial Distribution

  • EIBASNMR03501022150 ()
SNMR-035-010-2215

  • Radiological image marker, implantable
0.35mm x 1.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle.
Izi Medical Products, LLC
SNMR-035-010-2208
In Commercial Distribution

  • EIBASNMR03501022080 ()
SNMR-035-010-2208

  • Radiological image marker, implantable
0.50mm x 2.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-050-020-PL15
In Commercial Distribution

  • EIBASN050020PL150 ()
SN-050-020-PL15

  • Radiological image marker, implantable
0.50mm x 2.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-050-020-PL08
In Commercial Distribution

  • EIBASN050020PL080 ()
SN-050-020-PL08

  • Radiological image marker, implantable
0.50mm x 1.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-050-010-PL15
In Commercial Distribution

  • EIBASN050010PL150 ()
SN-050-010-PL15

  • Radiological image marker, implantable
0.50mm x 1.0cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-050-010-PL08
In Commercial Distribution

  • EIBASN050010PL080 ()
SN-050-010-PL08

  • Radiological image marker, implantable
0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-050-005-PL15
Not in Commercial Distribution

  • EIBASN050005PL150 ()
SN-050-005-PL15

  • Radiological image marker, implantable
0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-050-005-PL08
In Commercial Distribution

  • EIBASN050005PL080 ()
SN-050-005-PL08

  • Radiological image marker, implantable
0.35mm x 2.0cm VISICOIL loaded in an 22 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-035-020-PL15
In Commercial Distribution

  • EIBASN035020PL150 ()
SN-035-020-PL15

  • Radiological image marker, implantable
0.35mm x 2.0cm VISICOIL loaded in an 22 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-035-020-PL08
In Commercial Distribution

  • EIBASN035020PL080 ()
SN-035-020-PL08

  • Radiological image marker, implantable
0.35mm x 1.0cm VISICOIL loaded in an 22 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
SN-035-010-PL15
In Commercial Distribution

  • EIBASN035010PL150 ()
SN-035-010-PL15

  • Radiological image marker, implantable
0.35mm x 1.0cm Visicoil loaded into a pre-waxed 22 gauge brachytherapy needle.
Izi Medical Products, LLC
SN-035-010-PL08
In Commercial Distribution

  • EIBASN035010PL080 ()
SN-035-010-PL08

  • Radiological image marker, implantable
0.35mm x 0.5cm VISICOIL loaded into an 22g pre-waxed needle.
Izi Medical Products, LLC
SN-035-005-PL15
In Commercial Distribution

  • EIBASN035005PL150 ()
SN-035-005-PL15

  • Radiological image marker, implantable
0.35mm x 0.5cm VISICOIL loaded into an 22 gauge pre-waxed needle.
Izi Medical Products, LLC
SN-035-005-PL08
In Commercial Distribution

  • EIBASN035005PL080 ()
SN-035-005-PL08

  • Radiological image marker, implantable
Visicoil Multi-Market Patient Convenience Kit: Quantity of 8: SN-050-005-PL08. Which contains: 0.50mm x 0.5cm VISICOIL loaded in an 21 gauge pre-waxed brachytherapy needle.
Izi Medical Products, LLC
KIT-SPN-8PL
In Commercial Distribution

  • EIBAKITSPN8PL0 ()
KIT-SPN-8PL

  • Radiological image marker, implantable
This device is used to acquire transaxial images of any desired region of the body, providing a wide range of diagnostic capabilities.
CANON MEDICAL SYSTEMS CORPORATION
PCD-1000A
In Commercial Distribution

  • 04987670103810 ()


  • PET/CT system
The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.
IB Lab GmbH
V2.11
Not in Commercial Distribution

  • 09120105730471 ()
  • 09120105730464 ()


  • X-ray image interpretive software
The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.
IB Lab GmbH
V2.05
Not in Commercial Distribution

  • 09120105730082 ()
  • 09120105730037 ()


  • X-ray image interpretive software
The product “Synapse 3D” is a system that receives and retrieves DICOM data from modalities including CT, MR, PET, XA, etc. and constructs 3D images and performs image analysis.
FUJIFILM CORPORATION
Synapse 3D
In Commercial Distribution

  • 04547410324877 ()


  • Radiology picture archiving and communication system workstation
SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use in diagnostic support. The device displays two and three dimensional images for each examined anatomical region. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
Epica Medical Innovations LLC
9801101000
Not in Commercial Distribution

  • 86000594161101 ()
86000594161101

  • Cone beam computed tomography system, head/neck
0.35mm x 2.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle.
Izi Medical Products, LLC
SHZ-035-020-22
In Commercial Distribution

  • SHZ03502022 ()
SHZ-035-020-22

  • Radiological image marker, implantable
0.35mm x 1.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle.
Izi Medical Products, LLC
SHZ-035-010-22
In Commercial Distribution

  • SHZ03501022 ()
SHZ-035-010-22

  • Radiological image marker, implantable
0.35mm x 0.5cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 38.5cm needle.
Izi Medical Products, LLC
SHZ-035-005-22
In Commercial Distribution

  • SHZ03500522 ()
SHZ-035-005-22

  • Radiological image marker, implantable
< 1 ... 46 47 48 49 50 ... 58 >