KAR

FDA 510(k)

FDA Class 2 ·Orthopedic

KAR-D-TEK

FDA 510(k)

FDA Class 2 ·Dental

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

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

Automatic Anatomy Recognition (AAR)

FDA 510(k)

FDA Class 2 ·Radiology

BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION

FDA 510(k)

FDA Class 2 ·Dental

MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV Assay

DICOM VIDEO

FDA 510(k)

FDA Class 2 ·Radiology

ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)

FDA 510(k)

FDA Class 2 ·General Hospital

H-FLOW VALVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

BACSTOP

FDA 510(k)

FDA Class 2 ·General Hospital

DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD

FDA 510(k)

FDA Class 2 ·General Hospital

SAFEPORT MANIFOLD (TM) (OR STOPCOCK)

FDA 510(k)

FDA Class 2 ·General Hospital