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.

Influenza A Virus Subtype Differentiation Nucleic Acid Assay

FDA classification

FDA Class 2 ·Influenza A Virus Subtype Differentiation Nucleic Acid Assay

Over-The-Counter Device To Assess Risk Of Sleep Apnea

FDA classification

FDA Class 2 ·Over-The-Counter Device To Assess Risk Of Sleep Apnea

Device To Detect Microbial Colonization Directly From Clinical Specimens.

FDA classification

FDA Class 2 ·Device To Detect Microbial Colonization Directly From Clinical Specimens.

FM-9000 PLUS FETAL AND MATERNAL MONITOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AQUILEX FLUID CONTROL SYSTEM H112

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CABOT FIBER LASER PROBE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DOUBLE PUNCTURE INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CONCEPTUS UTERINE CATHETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OASIS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DOPPLER (UTD-5 & UTD-6)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology