Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Avitene® Microfibrillar Collagen Hemostat

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GUIDANT VITALITY FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DISCOVERY/MERIDIAN

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Urinary)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System and Ascenda Intrathecal Catheters

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System and Percept PC BrainSense

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Bowel)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera/MRI/DF, ICD, S DR, XT DR, S VR, XT VR, Maximo II ICD, Secura DR ICD/ DR, Visia AF MRI DFI ICD/VR ICD

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET XMI THROMBECTOMY SET, ANGIOJET SPIROFLEX THROMBECTOMY SET, ANGIOJEET SPIROFLEX VG THROMBECTOMY SET, ANGIOJET DI

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), and DI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF ICD /MRI ICD / S DR / S VR / XT DR /XT VR ICD's; Visia AF MRI DFI ICD / AF MRI VR ICD / AF VR ICD.

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-I ICD,EVERA MRI ICD, Evera S DR/S VR/XT DR/ XT VR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maxmo II ICD,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-I ICD/Evera MRI ICD/ Evera S DR ICD/Evera S VR ICD/ Evera XT DR ICD/ Evera XT VR ICD/ Visia AF MRI DF1 ICD/

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-I ICD / Evera MRI ICD/ S DR ICD / S VR ICD / XT DR ICD /XT VR ICD ; Mirro MRI DR ICD / MRI VR ICD; Primo MR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF ICD, MRI ICD, S DR ICD, S VR ICD, XT DR ICD, XT VR ICD - Visia AF MRI DFI ICD, AF MRI VR ICD, AF VR ICD

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (PEDIATRIC)

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

Immunohistochemistry Assay, Antibody, Met

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Met