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REFINEMENT CORRECTION
Access Dental Lab, LLC
100-0012
- Orthodontic progressive aligner
Mid-Course Correction aligners
Access Dental Lab, LLC
100-0010
- Orthodontic progressive aligner
Sequential -initial
Access Dental Lab, LLC
100-0352
- Orthodontic progressive aligner
PNEUMOSTOP® PLUS DEVICE
LSI Solutions, Inc.
110230
110230
- Laparoscopic hysterectomy vaginal occluder
PNEUMOSTOP® DEVICE
LSI Solutions, Inc.
110200
110200
- Laparoscopic hysterectomy vaginal occluder
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.3.0
- MRI image interpretive software
LiNA OperåScope™ with HDMI cable & LCD intended for hysteroscopy and cystoscopy
Lina Medical ApS
OP-201-6
- Rigid video hysteroscope
Cautery Tip Cleaner, 50mm x 50mm, sterile, pouch
KEY SURGICAL, INC.
Cautery Tip Cleaner
TC200
- Electrosurgical tip cleaning pad
Flexistem Ultrafine Cleaner, 6mil. x 6and#039; Roll
KEY SURGICAL, INC.
Pipe Cleaner
PC606
- Surgical instrument/endoscope cleaning utensil, single-use
Pipe Cleaner, 1/4-inch Polyester, 50 feet
KEY SURGICAL, INC.
Pipe Cleaner
PC400P
- Surgical instrument/endoscope cleaning utensil, single-use