Monarch Endoscopy Platform (Monarch Platform)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cionic Neural Sleeve NS-100

FDA 510(k)

FDA Class 2 ·Neurology

STEALTH DILATION CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SAS PREGNANCY STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

MILLENNIUM

FDA 510(k)

FDA Class 2 ·Dental

INTRAUTERINE DELIVERY SYSTEM - INJECTOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ARGESOL-Y

FDA 510(k)

FDA Class 2 ·Dental

RAPIDVUE(TM) HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Zio AT ECG Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITAACCESS (TM) CATHETER INTRODUCER SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFIED IVT PERIPHERAL ATHERECTOMY

FDA 510(k)

FDA Class 2 ·Cardiovascular

Visi Mobile Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.

FDA 510(k)

FDA Class 2 ·Microbiology

VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES

FDA 510(k)

FDA Class 2 ·General Hospital

SAS SALMONELLA 0 FACTOR 23 ANTISERUM AND/OR SAS SLAMONELLA 0 GROUP G2 FACTOR 23 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology