ACUMED WRIST ARTHRODESIS PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Viberect Penile Vibratory Stimulation Device

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DIRECTVISION GUIDE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACUMED SUTURE ANCHOR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF

FDA 510(k)

FDA Class 2 ·Orthopedic

Bunny Wax Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ivWatch Model 400

FDA 510(k)

FDA Class 2 ·General Hospital

Cervical Plate

FDA 510(k)

FDA Class 2 ·Orthopedic

Progenix Select Stim

FDA 510(k)

FDA Class 2 ·Neurology

Edge Insulated Blade Electrode

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PADCHECK

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTERFACE BONE VOID FILLER

FDA 510(k)

FDA Class 2 ·Orthopedic

ZOU ANTERIOR LUMBAR PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Utepreva Endometrial Sampler (UP01)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OSSE-LIGN

FDA 510(k)

FDA Class 2 ·Orthopedic

VASCON POLARIS GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Barrx FLEX RFA Energy Generator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

1.5T GEM FLEX COIL

FDA 510(k)

FDA Class 2 ·Radiology