KAR

FDA 510(k)

FDA Class 2 ·Orthopedic

CZR PRESS

FDA 510(k)

FDA Class 2 ·Dental

CZR PRESS LF

FDA 510(k)

FDA Class 2 ·Dental

KAR-D-TEK

FDA 510(k)

FDA Class 2 ·Dental

CZR PRESS LF STAINS

FDA 510(k)

FDA Class 2 ·Dental

MEMOMETAL INTRA-MEDULLARY BONE FASTENER

FDA 510(k)

FDA Class 2 ·Orthopedic

Kangbeier Surgical Mask (Model: KBR-1001)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

Ultrasound, Cyclodestructive

FDA Pre-Market Approval

FDA Class 2 ·THERAPEUTIC ULTRASOUND FOR TREATMENT OF GLAUCOMA

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

MEMOMETAL FIXOS SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic