BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.)

FDA 510(k)

FDA Class 2 ·General Hospital

TRILUX, Z-TONE, ACRY ROCK

FDA 510(k)

FDA Class 2 ·Dental

ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PARTNER INFUSION SYSTEM:

FDA 510(k)

FDA Class 2 ·General Hospital

EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS

FDA 510(k)

FDA Class 2 ·General Hospital

ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.

FDA 510(k)

FDA Class 2 ·General Hospital

U2 Total Knee System E-XPE products

FDA 510(k)

FDA Class 2 ·Orthopedic

(MULTIPLE) DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

S90 Exp Series Digital Color Doppler Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

HM70 EVO Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SKORE (Colors & Flavors), SKORE (Colors)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

E-XPE Acetabular Components and U-Motion II Acetabular Cup

FDA 510(k)

FDA Class 2 ·Orthopedic