Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM

Adaptive Biotechnologies clonoSEQ Assay

FDA 510(k)

FDA Class 2 ·Pathology

Adaptive Biotechnologies clonoSEQ Assay

FDA 510(k)

FDA Class 2 ·Pathology

Apollo ESG NXT System, Apollo REVISE NXT System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BSM- BONE SUBSTITUTE MATERIAL

FDA 510(k)

FDA Class 2 ·Neurology

ONE DIRECTIONAL CLEANING BRUSH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JETLITE

FDA 510(k)

FDA Class 2 ·Dental

COE-LITE POLYMERIZATION UNIT

FDA 510(k)

FDA Class 2 ·Dental

SYSTEM 83 PLUS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cereve Sleep System

FDA 510(k)

FDA Class 2 ·Neurology

ORTHOLUX XT

FDA 510(k)

FDA Class 2 ·Dental

PARALLAX CRANIOSET

FDA 510(k)

FDA Class 2 ·Neurology

CBC-CAL PLUS HEMATOLOGY CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

Ascent 3D

FDA 510(k)

FDA Class 2 ·Dental

KULZER TRANSLUX VISIBLE LIGHT CURING

FDA 510(k)

FDA Class 2 ·Dental

OP II VISIBLE LIGHT CURING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

CURING LIGHT COVER

FDA 510(k)

FDA Class 2 ·Dental

Advantage Plus Pass-Thru

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology