Antigen, Treponema Pallidum For Fta-Abs Test

FDA classification

FDA Class 2 ·Antigen, Treponema Pallidum For Fta-Abs Test

Hettich Labinstrument

Importer

🇩🇰 Denmark·3 Manufacturers

REI-90/90 RADIOGRAPHIC TABLE

FDA 510(k)

FDA Class 2 ·Radiology

OXLIFE

FDA 510(k)

FDA Class 2 ·Anesthesiology

REI-90/15

FDA 510(k)

FDA Class 2 ·Radiology

REI-38 RADIOGRAPHIC TABLE

FDA 510(k)

FDA Class 2 ·Radiology

MST-1050-II X-RAY UNIT

FDA 510(k)

FDA Class 1 ·Pathology

Elers Medical Finland Oy

Importer

🇫🇮 Finland·6 Manufacturers

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CLERZ LUBRICATING & REWETTING EYE DROPS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, and DISCOVISC™ Ophthalmic Viscosurgic

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·FLEXSOL

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT/DUOVISC Ophthalmic Viscoelastic System

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·PREFLEX AND FLEX CARE SOLUTIONS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS B-13F (P-10) & B-1H (P-11)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IOL LENS MODEL GR1A

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT, DISCOCISC Ophthalmic Viscosurgical Device

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM