Surgical face mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY

Tek RMD (Tek Robotic Mobilization Device)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

OSSIX BONE

FDA 510(k)

FDA Class 2 ·Dental

OSSIX VOLUMAX

FDA 510(k)

FDA Class 2 ·Dental

OSSIX PLUS

FDA 510(k)

FDA Class 2 ·Dental

OSSIX Breeze

FDA 510(k)

FDA Class 2 ·Dental

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·D114S/NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter

STERISPINE PS

FDA 510(k)

FDA Class 2 ·Orthopedic

Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CINA-VCF

FDA 510(k)

FDA Class 2 ·Radiology

CINA-ASPECTS

FDA 510(k)

FDA Class 2 ·Radiology

Sterispine™ PS

FDA 510(k)

FDA Class 2 ·Orthopedic

CINA-iPE

FDA 510(k)

FDA Class 2 ·Radiology

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

Helianthus

FDA 510(k)

FDA Class 2 ·Radiology

YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology