ClearPoint System

FDA 510(k)

FDA Class 2 ·Neurology

CLEARPOINT SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW PTCA CATHETER AND QUANTUM MAVERICK OTW PTCA CATHETER

NaviENT

FDA 510(k)

FDA Class 2 ·Neurology

POLYURETHANE SOLUTION 29% W/W

FDA 510(k)

FDA Class 2 ·Dental

Navident

FDA 510(k)

FDA Class 2 ·Dental

Navident

FDA 510(k)

FDA Class 2 ·Dental

BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208

FDA 510(k)

FDA Class 2 ·Cardiovascular

FUJINON EVL-F

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MyClearALIGN Dental Aligner System

FDA 510(k)

FDA Class 2 ·Dental

Visualase V2 MRI-guided Laser Ablation System (9736422)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Visualase MRI-Guided Laser Ablation System (SW 3.4)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Monteris Medical NeuroBlate System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRANBERG Thermoguide Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK XL PTCA DILATATION CATHETER

Portable Wheelchair

FDA 510(k)

FDA Class 2 ·Physical Medicine

Powered Mobility Scooter

FDA 510(k)

FDA Class 2 ·Physical Medicine

Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY TFC UNITE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY