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No Description
Biomet Orthopedics, LLC
909849
In Commercial Distribution
- 00880304979598 ()
909849
- Ligament reconstruction instrument set, reusable
No Description
Biomet Orthopedics, LLC
909848
In Commercial Distribution
- 00880304979581 ()
909848
- Ligament reconstruction instrument set, reusable
The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation.
The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005878 ()
DSC014-03-US
- Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005861 ()
D4D0192
- Basic diagnostic x-ray system application software
No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
91005-500ML
In Commercial Distribution
- 00857515006160 ()
- Total Volume: 500 Milliliter
91005
- Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Chang Medium BMC with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
91004-500ML
In Commercial Distribution
- 00857515006153 ()
- Total Volume: 500 Milliliter
91004
- Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Product Box also contain OS-SPA DI 00850391007146
ABYRX, INC.
OS-101
In Commercial Distribution
- 00850391007160 ()
- 00850391007139 ()
- Bone wax, synthetic
Product Box also contains OS-SPA DI 00850391007146
ABYRX, INC.
OS-201
In Commercial Distribution
- 00850391007153 ()
- 00850391007023 ()
- Bone wax, synthetic
Syndex with Constrictor® Technology for Syndesmosis Repair
DUNAMIS MEDICAL, LLC
MSYN0000
In Commercial Distribution
- 00854629006727 ()
MSYN0000
- Orthopaedic fixation suture button
- Fluted surgical drill bit, single-use
Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
RESPIRE MEDICAL HOLDINGS LLC
SPPD030US
Not in Commercial Distribution
- 00851861007246 ()
- Circumference: 200 Millimeter
- Mandible-repositioning sleep-disordered breathing orthosis