INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

READMYHEART, MODEL RMH2.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

READMYHEART, MODEL RMH3.0

FDA 510(k)

FDA Class 2 ·Cardiovascular

LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA

FDA 510(k)

FDA Class 2 ·General Hospital

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV TEST VERSION 2.0

ELECTRONIC CELL ENERGIZER

FDA 510(k)

FDA Class 2 ·Physical Medicine

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

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

FDA Pre-Market Approval

FDA Class 2 ·ROCHE MOLECULAR SYSTEMS COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

COSMED K5 Wearable Metabolic Technology

FDA 510(k)

FDA Class 2 ·Anesthesiology

ELECTRONIC PULSE STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

Wearable Breast Pump (Model S10)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

FDA 510(k)

FDA Class 2 ·Immunology

electrocardiograph: SE-1202

FDA 510(k)

FDA Class 2 ·Cardiovascular

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