TOTIM Patient Cushion Immobilization System

FDA 510(k)

FDA Class 2 ·Radiology

AUTONEB ACCESSORY CROSS (AAC)

FDA 510(k)

FDA Class 2 ·Anesthesiology

ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SENSUA!

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OMNIPORT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AWARE PAD

FDA 510(k)

FDA Class 2 ·Radiology

OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FilmArray Warrior Control Panel M290

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire RP2.1/RP2.1plus Control Panel M441

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray RP EZ Control Panel M265

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray RP2/RP2plus Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray BCID2 Control Panel M416

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Pneumonia/Pneumoniaplus Control

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire JI Control Panel M420

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control

FDA 510(k)

FDA Class 2 ·Microbiology

EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES

FDA 510(k)

FDA Class 2 ·Dental

LASER SYSTEM YELLOWSTAR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery