Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·FC2 FEMALE CONDOM

Home Uterine Activity Monitor

FDA Pre-Market Approval

FDA Class 2 ·CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·F C FEMALE CONDOM

Home Uterine Activity Monitor

FDA Pre-Market Approval

FDA Class 2 ·SYSTEM 37 HOME UTERINE ACTIVITY MONITORING SYSTEM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY(TM) VAGINAL POUCH

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·FC2 FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

VERSION 5 OPERATING SYSTEM SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

ALTAIRE INTERVENTIONAL MR PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE

FDA 510(k)

FDA Class 2 ·Radiology

CLAMPEASE FA

FDA 510(k)

FDA Class 2 ·Cardiovascular

M & R DISPOSABLE ELECTRODE (14200)

FDA 510(k)

FDA Class 2 ·Neurology

MAYFIELD ADULT DISPOSABLE SKULL PIN

FDA 510(k)

FDA Class 2 ·Neurology

ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000

FDA 510(k)

FDA Class 2 ·Radiology

VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery