Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HEALON DUET DUAL PACK

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE

FDA Pre-Market Approval

CONCERTO/CONCERTOI II. CONSULTA, VARIOUS INSYNC MODELS, MAXIMO II, PROTECTA/PROTECTS XT

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SYNCRA CRT-P, CONSULTA CRT-P, INSYNC CRT-P, INSYNC III CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA, AT500, ENRHYTHM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST, INSTRINSIC, MARQUIS, SECURA, VARIOUS MODELS OF MAXIMO, PROTECTA, & VIRTUOSO

HEARING AID 47 SERIES

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

TINNITUS AID, MODEL S244

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PURE-AID PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ORAL SLEEP DISORDER AID

FDA 510(k)

FDA Class 2 ·Dental

MODEL 342 HEARING AIDS

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

PULMO-AIDE MODEL 5610D

FDA 510(k)

FDA Class 1 ·Anesthesiology

MODEL WHO1 HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

SATOBAN FIRST AID TAPE

FDA 510(k)

FDA Class 1 ·General Hospital

LORI-CIC HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

MODEL CA, HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat