Radio Frequency System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC

FDA 510(k)

FDA Class 2 ·General Hospital

Cellene CO2 Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Denture Base Resin (PN-Denture (Red, White))

FDA 510(k)

FDA Class 2 ·Dental

Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)

FDA 510(k)

FDA Class 2 ·Physical Medicine

SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)

FDA 510(k)

FDA Class 2 ·Radiology

INFANT INCUBATOR

FDA 510(k)

FDA Class 2 ·General Hospital

ProPerformance Recovery System

FDA 510(k)

FDA Class 2 ·Physical Medicine

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PRECISION(TM) UV (VASURFILCON)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CSI (CROFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS

XIDF-AWS801, Angio Workstation, v5.31

FDA 510(k)

FDA Class 2 ·Radiology

DJF Intravascular Administration Set

FDA 510(k)

FDA Class 2 ·General Hospital

Hi-Torque Command 18 Guide Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular

CES VASCULAR OCCLUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ATRICURE TRANSPOLAR SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CES VASCULAR OCCLUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology