ETEST SUBMISSION FOR VANCOMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

ETEST VORICONAZOLE 0.002-32 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

EveryWare

FDA 510(k)

FDA Class 2 ·Anesthesiology

BREAS VIVO 40 SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

PROVOX FREEHANDS HME, MODEL 7710

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Delta4 Insight

FDA 510(k)

FDA Class 2 ·Radiology

AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

G-RINSE, MODEL 10031

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12

FDA 510(k)

FDA Class 2 ·Orthopedic

BREAS, MODEL HA01

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT

FDA 510(k)

FDA Class 2 ·Anesthesiology

CellaVision DC-1, CellaVision DC-1 PPA

FDA 510(k)

FDA Class 2 ·Hematology

Kit Boxes and Kit Plates

FDA 510(k)

FDA Class 2 ·General Hospital

BREAS ISLEEP 20+

FDA 510(k)

FDA Class 2 ·Anesthesiology

KIDNEY ASSIST-transport

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INVIDOS

FDA 510(k)

FDA Class 2 ·Radiology

(MODIFIED) ETEST PACKAGE INSERT

FDA 510(k)

FDA Class 2 ·Microbiology

ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.

FDA 510(k)

FDA Class 2 ·Anesthesiology

ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)

FDA 510(k)

FDA Class 2 ·Anesthesiology