FLEXI-FLATE PENILE IMPLANT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THE INFLATABLE PENILE PROSTHESIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURGIKEK PENILE PROSTHESIS TAIL EXTEND

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MENTOR MODIFIED MALLEABLE PENILE PROSTHESES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MINNOW PENILE IMPLANT PROTECTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MENTOR CORPORAL DILATORS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Rigi10 Malleable Penile Prosthesis

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ERECTAID

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·OSTEOSPACE

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS

SABA Tampons

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anti-HCV II, PreciControl Anti-HCV

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS

FDA 510(k)

FDA Class 2 ·Dental

Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow

FDA 510(k)

FDA Class 2 ·Dental

ri-former Predictive Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology