Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Paragon HDS 100 and Fluoroperm 151 (paflufocon D) Rigid Gas Permeable Contact Lens in Clear and Tints

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FLUOROCON TM-60

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Menicon Z (tisilfocon) Rigid Gas Permeable Contact Lens and Menicon Z Night (tisilfocon A) Contact Lenses for Overnight

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·MENICON SF-P RGP (MELAFOCON A) CONTACT LENS

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BOSTON ORTHOKERATOLOGY SHAPING LENS FOR OVERNIGHT WEAR

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BOSTON EQUALENS (ITAFLUOROFOCON A) RIGID GAS PERMEABLE CONTACT LENS, EQUALENS 2 (OPRIFOCON A) RIGID GAS PERMEARABLE LENS

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Paragon HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contac

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Paragon HDS100 and Fluoroperm 151 Rigid Gas Permeable Contact Lenses in clear and tints

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Boston Equalens II (oprifocon A) Rigid Gas Permeabl

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BOSTON EQUALENS/EQUALENS II

1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS

FDA 510(k)

FDA Class 3 ·Unknown

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 2 AND EASYTRAK 2 IS-1 CORONARY VENOUS STEROID ELUTING BIPOLAR PACE/SENSE LEAD AND EASYTRAK FINISHING WIRE MODE0

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Y Adaptor/Extender Kit, DF-1/IS-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, Lead Adaptor, Sprint Quatro Lead, Su

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK® 2 1S-1 Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead, EASYTRAK® 3 IS-1 Coronary Venous Steroid-Eluti

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA 2, RHA 3, RHA 4

Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

FDA Pre-Market Approval

FDA Class 3 ·Et Control

Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

FDA Pre-Market Approval

FDA Class 3 ·MAGE-A4 IHC 1F9 pharmDx

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·IPRO2 CGM SYSTEM WITH ENLITE SENSOR