COVER-ALL MALE INCONTINENCE DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Vessel Guard Or Cover

FDA classification

FDA Class 2 ·Vessel Guard Or Cover

Tracheal Prosthesis With Cover Material Derived From Human Sources

FDA classification

FDA Class 2 ·Tracheal Prosthesis With Cover Material Derived From Human Sources

External Condom For Anal Intercourse Or Vaginal Intercourse

FDA classification

FDA Class 2 ·External Condom For Anal Intercourse Or Vaginal Intercourse

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Hand-held IPL device (JOVS Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Hand-held IPL device(JOVS Graphene Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ST-302 INFRAREX

FDA 510(k)

FDA Class 2 ·Physical Medicine

SD-970EMS ELECTRICAL MUSCULAR STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

SAFE-CONNECT I.V. EXTENSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

SD-956 ULTRASOUND THERAPY

FDA 510(k)

FDA Class 2 ·Physical Medicine

GB-1002 TENS WITH MASSAGE

FDA 510(k)

FDA Class 2 ·Neurology

SAFECONNECT VALVE (CATALOG NO. XXXX)

FDA 510(k)

FDA Class 2 ·General Hospital

IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II

FDA 510(k)

FDA Class 2 ·Physical Medicine

PGS123 AND HVS-123

FDA 510(k)

FDA Class 2 ·Neurology

SD-602 SD MODE 11, SD-603 SD MOD 111

FDA 510(k)

FDA Class 2 ·Neurology

STAT-TENS

FDA 510(k)

FDA Class 2 ·Neurology

SD-100 SKYEAR THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)

FDA 510(k)

FDA Class 2 ·Neurology

SD-605 SD II PROGRAM

FDA 510(k)

FDA Class 2 ·Neurology