Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·SPINAL-STIM SPINAL FUSION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·LCS(R)TOTAL KNEE SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA classification

FDA Class 3 ·System, Test, Her-2/Neu, Nucleic Acid Or Serum

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL Z9000

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval

FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AARIS AND AARIS WITH ADAPTIV OPTICS INTRAOCULAR LENS

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE 2 HPV DNA TEST

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANEURX STENT GRAFT SYSTEM

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·TECNIS TORIC 1-PEICE INTRAOCULAR LENS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·SPINAL-STIM LITE, MODELS 212L AND 212LE. SPINAL FUSION SYSTEM

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Synergy Intraocular Lens, TECNIS Synergy Toric II Intraocular Lens, TECNIS Synergy IOL with TECNIS Simplicity Del

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AXSYM, AUSAB

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS