S-610 SHUNT ADAPTOR SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Adapter, A-V Shunt Or Fistula

FDA classification

FDA Class 2 ·Adapter, A-V Shunt Or Fistula

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)

FDA 510(k)

FDA Class 2 ·Dental

MEMOMETAL INTRA-MEDULLARY BONE FASTENER

FDA 510(k)

FDA Class 2 ·Orthopedic

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

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

KNH Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR

FDA 510(k)

FDA Class 2 ·Radiology

SANDMAN

FDA 510(k)

FDA Class 2 ·Neurology

MMC AMPLIFIER

FDA 510(k)

FDA Class 2 ·Neurology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·FULL FIELD DIGITAL MAMMOGRAPHY

MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)

FDA 510(k)

FDA Class 2 ·Orthopedic

MEMOMETAL FIXOS SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic