Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DROMOS DRISK RATE ADAPTIVE PACEING SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRP-T) SYSTME

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Mobi-C Cervical Disc Prosthesis (One-Level Indication)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Prospera SCS System, Resilience Surgical Lead, Embrace One

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Mobi-C Cervical Disc Prosthesis (one-level indications)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Mobi-C® Cervical Disc Prosthesis One-Level

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista One-Piece Foldable Acrylic Intraocular Lens (IOL)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ONE PIECE (NON-CM) TM POSTERIOR CHAMBER LENSES

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista One Piece Hydrophobic Acrylic Intraocular LEns (IOL)

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SYNVISC & SYNVISC-ONE (HYLAN G-F 20)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-ABSORBING ONE-PIECE PMMA ANTERIOR CHAMBER IOL

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SYNVISC & SYNVISC-ONE (HYLAN G-F 20)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS ONE PIECE SOFT ACRYLIC INTRAOCULAR LENS (IOL)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MynxGrip Vascular Closure Device, Mynx Control Vascular Closure Device (VCD)

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·DAKOCYTOMATION HERCEP TEST