HEALTH-E-CONNECT SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini

FDA 510(k)

FDA Class 2 ·Microbiology

VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System

FDA 510(k)

FDA Class 2 ·Ophthalmic

Celerity Incubator

FDA 510(k)

FDA Class 2 ·General Hospital

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE FILMARRAY Tropical Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)

FDA 510(k)

FDA Class 2 ·Pathology

MEMOMETAL INTRA-MEDULLARY BONE FASTENER

FDA 510(k)

FDA Class 2 ·Orthopedic

OSSIFUSE BONE SUBSTITUTE MATERIAL

FDA 510(k)

FDA Class 2 ·Orthopedic

SELITHERM, MODEL C100

FDA 510(k)

FDA Class 2 ·Physical Medicine

PEEP VALVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAXVIEW DIAGNOSTIC WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

FEATHERLITE DIODE LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LATERAL FLARE INTERNAL COLLAR (LFIC)

FDA 510(k)

FDA Class 2 ·Orthopedic

DIOSCAN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SANDMAN

FDA 510(k)

FDA Class 2 ·Neurology

MMC AMPLIFIER

FDA 510(k)

FDA Class 2 ·Neurology

MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)

FDA 510(k)

FDA Class 2 ·Orthopedic