SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION

FDA 510(k)

FDA Class 2 ·General Hospital

HLS KNEETEC SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GIRARD SUNGLASSES (NON-PRESCRIPTION)

FDA 510(k)

FDA Class 1 ·Ophthalmic

OR-LIGHT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO: LIGAFIX INTERFERENCE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

FIDIS VASCULITIS, MODEL MX007

FDA 510(k)

FDA Class 2 ·Immunology

Plasma Edge System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120

FDA 510(k)

FDA Class 2 ·Hematology

Hexanium TLIF

FDA 510(k)

FDA Class 2 ·Orthopedic

S555 INTRAORAL DENTAL CAMERA

FDA 510(k)

FDA Class 1 ·Dental

Withings Thermo (Model SCT01)

FDA 510(k)

FDA Class 2 ·General Hospital

Easyret

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODIFICATION TO DIGIPAN

FDA 510(k)

FDA Class 2 ·Dental

Rayvolve PTX-PE

FDA 510(k)

FDA Class 2 ·Radiology

SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5

FDA 510(k)

FDA Class 2 ·Radiology

Ayers Rock Cervical interbody fusion system

FDA 510(k)

FDA Class 2 ·Orthopedic

SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION

FDA 510(k)

FDA Class 2 ·Orthopedic

ANI Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vitra 2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

B-SCAN OPTHALMIC ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology