COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI

FDA 510(k)

FDA Class 3 ·Cardiovascular

COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM

FDA 510(k)

FDA Class 3 ·Cardiovascular

MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS

FDA 510(k)

FDA Class 3 ·Cardiovascular

SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFICATION OF STERILITY CYCLE PARAMETERS

FDA 510(k)

FDA Class 3 ·Cardiovascular

BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY

FDA 510(k)

FDA Class 3 ·Cardiovascular

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA classification

FDA Class 3 ·Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

FDA classification

FDA Class 3 ·Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy

FDA classification

FDA Class 3 ·Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA classification

FDA Class 3 ·Covered Stent Vascular Connector, Hemodialysis Access Circuit

Multiple Use Blood Lancet For Multiple Patient Use

FDA classification

FDA Class 3 ·Multiple Use Blood Lancet For Multiple Patient Use

Bone Grafting Material, Dental, With Biologic Component

FDA classification

FDA Class 3 ·Bone Grafting Material, Dental, With Biologic Component

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA classification

FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA classification

FDA Class 3 ·Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMVISC (R)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biomedics Toric (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODIFIED J & C LOOP MODEL PA36