Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM POSITIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR AMOXICILLIN/CLAVULANIC ACID

PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

WINCO STRETCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

MODEL 2500A PALMSAT PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Visby Medical Sexual Health Test

FDA 510(k)

FDA Class 2 ·Microbiology

INVOTEC POLY-MESH MANDIBULAR TRAY

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

H500 Multi-Sensing Oximetry System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)

FDA 510(k)

FDA Class 2 ·Cardiovascular

INVOTEC MICROSCOPE DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIGITAL PULSE OXIMETER, MODEL 7500FO

FDA 510(k)

FDA Class 2 ·Cardiovascular

MF SC Facial Toning System

FDA 510(k)

FDA Class 2 ·Neurology

LIFESENSE, MODEL LS1-9R

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ultra Facial Toning System

FDA 510(k)

FDA Class 2 ·Neurology

JETPACK 2.0

FDA 510(k)

FDA Class 2 ·Radiology

REGIONAL OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso

FDA 510(k)

FDA Class 2 ·Cardiovascular

REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

Winco Model S550 Stretchair

FDA 510(k)

FDA Class 2 ·Physical Medicine