SMARTez elastomeric infusion pump

FDA 510(k)

FDA Class 2 ·General Hospital

Respiree Cardio-Respiratory Monitor

FDA 510(k)

FDA Class 2 ·Anesthesiology

Claritas iPET

FDA 510(k)

FDA Class 2 ·Radiology

THERMODILUTION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

F88 URE-SD/RD Flexible Ureteroscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PLANCET

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SERV MEDICAL CDSS

FDA 510(k)

FDA Class 2 ·Radiology

SuperSlyde Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm

FDA 510(k)

FDA Class 2 ·Anesthesiology

Ocular Peg

FDA classification

FDA Class 2 ·Ocular Peg

KONG®-TL VBR System and KONG® C VBR System

FDA 510(k)

FDA Class 2 ·Orthopedic

VADER® Pedicle System

FDA 510(k)

FDA Class 2 ·Orthopedic

icotec Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

icotec Cervical Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

VADER® Pedicle System, G21 Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

VADER® Pedicle System Navigated Instruments

FDA 510(k)

FDA Class 2 ·Neurology

icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)

FDA 510(k)

FDA Class 2 ·Orthopedic

Ocular Peg, Exempt

FDA classification

FDA Class 2 ·Ocular Peg, Exempt

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA classification

FDA Class 2 ·Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

FDA classification

FDA Class 2 ·Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers