Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM)

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·GELSYN-3

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Bausch + Lomb Ultra (samfilcon A) Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY (COMFILCON A)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFTLENS66 TORIC (ALPHAFILCON A)VISIBILITY TINTED CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH & LOMB PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PUREVISION 2/PUREVISION 2 MULTI-FOCAL/PUREVISION 2 TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENS)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENS

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV 16 18/45 GENOTYPE ASSAY

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV 16 18/45 GENOTYPE ASSAY

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDURANT II AUI STENT GRAFT SYSTEM