Kangbeier Surgical Mask (Model: KBR-1001)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AirRay Subdural Cortical Electrodes

FDA 510(k)

FDA Class 2 ·Neurology

KBL Sunlamp Products (= Device Bundling name)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ABR-2000

FDA 510(k)

FDA Class 2 ·Neurology

AUDIOSCREENER OAE + ABR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AUDIOSCREENER OAE+ABR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COMPUTERSCOPE CPS-ABR

FDA 510(k)

FDA Class 2 ·Neurology

MEMOMETAL INTRA-MEDULLARY BONE FASTENER

FDA 510(k)

FDA Class 2 ·Orthopedic

Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08)

FDA 510(k)

FDA Class 2 ·Physical Medicine

STACKED ABR FOR NAVIGATOR PRO

FDA 510(k)

FDA Class 2 ·Neurology

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