iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

FDA 510(k)

FDA Class 2 ·Immunology

Disposable Laryngeal Electrodes

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

FDA 510(k)

FDA Class 2 ·Immunology

Cloud Smart Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28

FDA 510(k)

FDA Class 2 ·Radiology

COOLBLU2 DENTAL RESIN CURING DEVICE

FDA 510(k)

FDA Class 2 ·Dental

Medical Disposable Sterile Needle Electrode

FDA 510(k)

FDA Class 2 ·Neurology

BV Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit

FDA 510(k)

FDA Class 2 ·Immunology

Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09

FDA 510(k)

FDA Class 2 ·Cardiovascular

Electrocardiograph

FDA 510(k)

FDA Class 2 ·Cardiovascular

AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION

FDA 510(k)

FDA Class 2 ·Orthopedic

ECAT VISION PET SCANNER, MODELS 3000 & 5000

FDA 510(k)

FDA Class 2 ·Radiology

ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART

FDA 510(k)

FDA Class 2 ·Radiology

ATI-PYMAH DISPOSABLE BIOLOGICAL TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

ECAT PET SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

ECAT PET SCANNERS

FDA 510(k)

FDA Class 2 ·Radiology

E.CAM LSO 311 PET/SPECT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ

FDA 510(k)

FDA Class 2 ·Radiology