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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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IPDmilled Analog Ø 3,3 MIC 5.La3.300
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566637674 ()
IPD/TB-AT-00/X

  • Dental implant analog
IPDmilled Analog Ø 4,5/5,0 S 5.La4.550
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566637629 ()
IPD/EA-AW-00/X

  • Dental implant analog
IPDmilled Analog Ø 3,5/4,0 S 5.La3.540
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566637612 ()
IPD/EA-AR-00/X

  • Dental implant analog
IPDmilled Analog Ø 4,5 BIO 5.La4.500
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566637582 ()
IPD/LB-AR-00/X

  • Dental implant analog
IPDmilled Analog Ø 3,0 BIO 5.La3.000
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566637568 ()
IPD/LB-AT-00/X

  • Dental implant analog
IPDmilled Analog Ø 5,0 COL 5.La5.000
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566637551 ()
IPD/JB-AW-00/X

  • Dental implant analog
IPDmilled Analog Ø 3,8/4,3 COL 5.La3.843
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566637544 ()
IPD/JB-AR-00/X

  • Dental implant analog
IPDmilled Analog Ø 6,5 WN N 5.La6.500
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566637520 ()
IPD/DA-AW-00/X

  • Dental implant analog
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
Compression Bandages,Cohesive,6"" x 15' (15.24 cm x 4.572 m)
Covidien LP
CB-CO-6 x 5
Not in Commercial Distribution

  • 20884521140216 ()
  • 10884521140219 ()
  • 30884521140213 ()

  • Width: 6 Inch
  • Length: 15 Feet
CB-CO-6 x 5

  • Wound compression dressing
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
Specimen Cups With Leak Proof Screw on Lids - 3.5oz 500
Avaline Medical NJ Limited Liability Company
Sc3.5 x 500
In Commercial Distribution

  • 00850025452939 ()
  • 00810077213469 ()
Sc3.5 x 500

  • Urine specimen collection kit IVD
Specimen Cups With Leak Proof Screw on Lids - 3.5oz 100
Avaline Medical NJ Limited Liability Company
Sc3.5 x 100
In Commercial Distribution

  • 00850025452939 ()
  • 00810077213452 ()
Sc3.5 x 100

  • Urine specimen collection kit IVD
Specimen Cups With Leak Proof Screw on Lids - 3.5oz 50
Avaline Medical NJ Limited Liability Company
Sc3.5 x 50
In Commercial Distribution

  • 00850025452939 ()
  • 00810077213445 ()
Sc3.5 x 50

  • Urine specimen collection kit IVD
Specimen Cups With Leak Proof Screw on Lids - 3.5oz 25
Avaline Medical NJ Limited Liability Company
Sc3.5 x 25
In Commercial Distribution

  • 00850025452939 ()
  • 00810077213438 ()
Sc3.5 x 25

  • Urine specimen collection kit IVD
Specimen Cups With Leak Proof Screw on Lids - 4oz [Pack of 5] Non-Sterile Urine Sample Containers
Avaline Medical NJ Limited Liability Company
nssc x 5
In Commercial Distribution

  • 00850025452618 ()
  • 00810077212745 ()
nssc x 5

  • Urine specimen collection kit IVD
Compression Bandages,Cohesive,4"" x 15' (10.16 cm x 4.572 m)
Covidien LP
CB-CO-4 x 5
Not in Commercial Distribution

  • 20884521140209 ()
  • 10884521140202 ()
  • 30884521140206 ()

  • Width: 4 Inch
  • Length: 15 Feet
CB-CO-4 x 5

  • Wound compression dressing
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
Surround 5.x
Gpi Usa, Inc.
5.x
In Commercial Distribution



  • Blood bank information system
No Description
Aiq Global, Inc.
2.x
In Commercial Distribution

  • 00860007104916 ()


  • Radiological PACS software
The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques. Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution

  • 00860002545707 ()


  • Ultrasound imaging system application software
Protect Grid and Image Receptor from Weight Bearing damage and position patient relative to Image Receptor
Reina Imaging
WDDR[X]
In Commercial Distribution

  • 00860001700176 ()


  • Footstool
  • Flat panel x-ray detector/film cassette weight-bearing protector
No Description
Whoop, Inc.
1.x
In Commercial Distribution

  • 00860012964819 ()


  • Electrocardiograph, home-use
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.3.x
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only
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