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Device Name: CERASORB® Ortho Foam
Mofidication: Mouldable Foam
Indication for Use:
Cerasorb® ORTHO Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb® Ortho Foam resorbs and is replaced with bone during healing process.
curasan AG
25x100x4 mm
In Commercial Distribution
- ECURCOM25100 ()
1 x 10.0cc
- Bone matrix implant, composite
Tapered Dental Implant 8.0mm in diameter and 20mm in Length
Suncoast Dental, Inc
Tapered/8.0x20
Not in Commercial Distribution
- 00083208080203 ()
- Outer Diameter: 8 Millimeter
- Length: 20 Millimeter
- Tapered Dental Implant 8.0mm in diameter and 20mm in Length
IT8.0 x 20mm
- Screw endosteal dental implant, two-piece
Tapered Dental Implant 7.0mm in diameter and 20mm in Length
Suncoast Dental, Inc
Tapered/7.0x20
Not in Commercial Distribution
- 00083208070204 ()
- Tapered Dental Implant 7.0mm in diameter and 20mm in Length
- Outer Diameter: 7 Millimeter
- Height: 20 Millimeter
IT7.0 x 20mm
- Screw endosteal dental implant, two-piece
Quad Channel Met-Traverse, 34mm x 10mm
Mios Marketing, LLC
Met-Traverse
In Commercial Distribution
- G2710620340100 ()
- Length: 34 Millimeter
- Depth: 10 Millimeter
34mm x 10mm
- Orthopaedic implant aiming/guiding block, single-use
Quad Channel Met-Traverse, 30mm x 14mm
Mios Marketing, LLC
Met-Traverse
In Commercial Distribution
- G2710620300140 ()
- Length: 30 Millimeter
- Depth: 14 Millimeter
30mm x 14mm
- Orthopaedic implant aiming/guiding block, single-use
Quad Channel Met-Traverse, 30mm x 10mm
Mios Marketing, LLC
Met-Traverse
In Commercial Distribution
- G2710620300100 ()
- Length: 30 Millimeter
- Depth: 10 Millimeter
30mm x 10mm
- Orthopaedic implant aiming/guiding block, single-use
SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal regions of the body, or increase image sharpness for head MRI.
Subtle Medical, Inc.
2.x
In Commercial Distribution
- 00860000171212 ()
- Radiology DICOM image processing application software
SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (FDG), amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA radiotracer PET images (including PET/CT and PET/MRI).
Subtle Medical, Inc.
2.x
In Commercial Distribution
- 00860000171205 ()
- Radiology DICOM image processing application software
Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist.
PAIGE.AI, INC.
1.X
In Commercial Distribution
- 00860007599118 ()
- Histology/cytology/microbiology image-analysis interpretive software IVD
FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus renders the uploaded slide images and is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis.
PAIGE.AI, INC.
2.X
In Commercial Distribution
- 00860007599101 ()
- Pathology information system