FLUOROPERM 151-OK, PARAGON HDS 100-OK

FDA 510(k)

FDA Class 2 ·Ophthalmic

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)

FDA 510(k)

FDA Class 2 ·Ophthalmic

AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY

FDA 510(k)

FDA Class 2 ·Ophthalmic

BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY

FDA 510(k)

FDA Class 2 ·Ophthalmic

FLUROPERM 60-OK, PARAGON HDS-OK

FDA 510(k)

FDA Class 2 ·Ophthalmic

Lens, Contact (Orthokeratology)

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES

Lens, Contact (Orthokeratology)

FDA Pre-Market Approval

FDA Class 2 ·PAFLUFOCON D RIGID GAS PERMEABLE CONTACT LENSES

Lens, Contact (Orthokeratology)

FDA classification

FDA Class 2 ·Lens, Contact (Orthokeratology)

Bladder Scanner (Models: M2, M2-W, M1, M1-W)

FDA 510(k)

FDA Class 2 ·Radiology

GLYCOMAT HAEMOGLOBIN ANALYSER

FDA 510(k)

FDA Class 2 ·Hematology

GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT

FDA 510(k)

FDA Class 2 ·Hematology

745 GLYCOMAT

FDA 510(k)

FDA Class 2 ·Hematology

UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program

FDA 510(k)

FDA Class 2 ·Radiology

DOPPLEX CENTRALE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MPW HEMODIALYSIS WATER PURIFICATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RHYTHMSTAR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMPAT ENTERAL DELIVERY PUMP SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SLEEP TEST(TM)

FDA 510(k)

FDA Class 2 ·Anesthesiology

INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1

FDA 510(k)

FDA Class 2 ·Cardiovascular