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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
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
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
Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
RESPIRE MEDICAL HOLDINGS LLC
SPPD000US
Not in Commercial Distribution
- 00851861007222 ()
- Circumference: 200 Millimeter
- Mandible-repositioning sleep-disordered breathing orthosis
Acessa ProVu Transducer with sensor, Reusable, connects to the Acessa ProVu Console
ACESSA HEALTH INC.
7700
In Commercial Distribution
- 00854763006188 ()
- Surgical ultrasound imaging transducer
Femoral Stem Impactor with Anteversion
TOTAL JOINT ORTHOPEDICS, INC.
1307.00.000
In Commercial Distribution
- 00819251021197 ()
- Orthopaedic implant impactor, reusable
CER-BD-A ASSEMBLY PACK
PN 69011-01M
RANFAC CORP.
CER-BD-A
In Commercial Distribution
- 00850023741639 ()
- Non-fixed blood collection needle
The Accuryn Monitor Mount with Clamp consists of a handle, monitor attachment piece, and clamp with knob. The monitor may be attached to an IV Pole with the pole-clamp and knob.
POTRERO MEDICAL, INC.
FGN-06-100202
In Commercial Distribution
- 00850019755237 ()
FGN-06-100202
- Portable active medical device mount
Mini sheath, 65cm – L2 with FlexCath Cross
ACUTUS MEDICAL, INC.
012852-005
In Commercial Distribution
- 00850027837697 ()
012852-005
- Cardiac transseptal access set