System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE(R) EIA

ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

TinniLogic Mobile Tinnitus Management Device

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

FDA 510(k)

FDA Class 2 ·Dental

PANTHEON SPINAL IBFD SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

STS 701 TRANSPORT STRETCHER

FDA 510(k)

FDA Class 2 ·General Hospital

Dental Glass Ceramics Blocks

FDA 510(k)

FDA Class 2 ·Dental

Youha electric breast pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

FDA Pre-Market Approval

FDA Class 2 ·P.C.A.(TM) TOTAL KNEE SYSTEM

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

FDA Pre-Market Approval

FDA Class 2 ·P.C.A.(TM) TOTAL KNEE SYSTEM

SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

PINSET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TIGER FLAT SURGICAL MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

1-Step Culture Medium

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY

FDA 510(k)

FDA Class 2 ·Radiology

DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9)

FDA 510(k)

FDA Class 2 ·General Hospital