Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)

FDA 510(k)

FDA Class 2 ·Neurology

Keffort (MC-100, MC-100A)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Electric wheelchair (YHWL002, YHWL003)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0

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

Diode laser device (RF3120-BI)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY

Twoplus Applicator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LED Curing Light

FDA 510(k)

FDA Class 2 ·Dental

PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TT Electric Breast Pump, TT Double Electric Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Numen Coil Embolization System; NumenFR Detachment System

FDA 510(k)

FDA Class 2 ·Neurology

CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres

FDA 510(k)

FDA Class 2 ·Cardiovascular

BioHealx Anal Fistula Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Numen Coil Embolization System; NumenFR Detachment System

FDA 510(k)

FDA Class 2 ·Neurology