SANARUS INDICA MARKER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SANARUS VISICA TREATMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NI-PACER 1

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOXANE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MYRIAN

FDA 510(k)

FDA Class 2 ·Radiology

PREMIO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

StimQ Peripheral Nerve Stimulator (PNS) System

FDA 510(k)

FDA Class 2 ·Neurology

Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder

FDA 510(k)

FDA Class 2 ·Dental

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit

FDA 510(k)

FDA Class 2 ·Neurology

Freedom Spinal Cord Stimulator System

FDA 510(k)

FDA Class 2 ·Neurology

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

FDA 510(k)

FDA Class 2 ·Neurology

NeumoFilt Ergo/Neumo Filt BiteOn

FDA 510(k)

FDA Class 2 ·Anesthesiology

Oxxiom

FDA 510(k)

FDA Class 2 ·Cardiovascular

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

FDA 510(k)

FDA Class 2 ·Neurology

SR-IVOCAP

FDA 510(k)

FDA Class 2 ·Dental

APOLLO CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VIVAALLOY HR (AMALGAM)

FDA 510(k)

FDA Class 2 ·Dental

FIBREFLEX

FDA 510(k)

FDA Class 2 ·Dental