Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PREFERRED PLUS 53 SOFT (HYDROPHILIC) ASPHERIC LENS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS ANTI-HCV

CAPILLARY SAMPLE LINE

FDA 510(k)

FDA Class 2 ·Anesthesiology

CO2/02 MONITOR MULTINEX

FDA 510(k)

FDA Class 2 ·Anesthesiology

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

CureOs TCP

FDA 510(k)

FDA Class 2 ·Orthopedic

FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Notal Vision Home Optical Coherence Tomography (OCT) System

FDA 510(k)

FDA Class 2 ·Ophthalmic

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

FDA 510(k)

FDA Class 2 ·Hematology

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

FDA 510(k)

FDA Class 2 ·General Hospital

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

System, Imaging, Optical Coherence Tomography (Oct)

FDA classification

FDA Class 2 ·System, Imaging, Optical Coherence Tomography (Oct)