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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test

ClariSIGMAM

FDA 510(k)

FDA Class 2 ·Radiology

Sterile NS System

FDA 510(k)

FDA Class 2 ·Neurology

CPL Insulin Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

WS80A Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

REXSIN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)

FDA 510(k)

FDA Class 2 ·Orthopedic

Sterile bone screw (PEEK ACL screw)

FDA 510(k)

FDA Class 2 ·Orthopedic

RetiCapture

FDA 510(k)

FDA Class 2 ·Ophthalmic

ON3D

FDA 510(k)

FDA Class 2 ·Radiology

Internal Octa Implant System

FDA 510(k)

FDA Class 2 ·Dental

BellaFuse

FDA 510(k)

FDA Class 2 ·Orthopedic

SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

MONOFIX PGCL, knotless wound closure device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HFT750U

FDA 510(k)

FDA Class 2 ·Anesthesiology

SuperLine

FDA 510(k)

FDA Class 2 ·Dental

UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SOFTXIL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)

FDA 510(k)

FDA Class 2 ·Orthopedic