PILOT TEST OR DETECTIVE AUDIOMETERS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LIAISON 25 TOTAL-D

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Radio Therapy Treatment Chair

FDA 510(k)

FDA Class 2 ·Radiology

ACCU-CHEK Connect Diabetes Management App

FDA 510(k)

FDA Class 2 ·Anesthesiology

SMARTBRACE ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP

FDA 510(k)

FDA Class 2 ·Orthopedic

Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR

FDA 510(k)

FDA Class 2 ·Neurology

SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

PILLAR PALATAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

SYDNEY IVF EMBRYO BIOPSY MEDIUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ILUMA VISION MODEL VERSION 2.2

FDA 510(k)

FDA Class 2 ·Radiology

Bio-Medicus Pediatric Cannula and Introducers

FDA 510(k)

FDA Class 2 ·Cardiovascular

6F ENGAGE/ENGAGE TR INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERI-DRAPE SURGICAL DRAPES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXTREME 4X4-X8 POWER WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine