PoreStar Patient Specific Implant

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

OVENT

FDA 510(k)

FDA Class 2 ·Dental

Patient Administration Set

FDA 510(k)

FDA Class 2 ·Radiology

Orion LifeSpan MEG

FDA 510(k)

FDA Class 2 ·Neurology

VECTORSURGE 5, MODEL VS-500

FDA 510(k)

FDA Class 2 ·Physical Medicine

C-Zero Pedicle Screw System, Freedom Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIOMECCA CARETAKER 1000 & 2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

Shoulder Soft Tissue Anchors

FDA 510(k)

FDA Class 2 ·Orthopedic

CONNEQT PULSE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

INTEGRE, MODEL LP581

FDA 510(k)

FDA Class 2 ·Ophthalmic

Annalise Enterprise CXR Triage Pneumothorax

FDA 510(k)

FDA Class 2 ·Radiology

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber

FDA 510(k)

FDA Class 2 ·Anesthesiology

Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range

FDA 510(k)

FDA Class 2 ·Orthopedic

Rover

FDA 510(k)

FDA Class 2 ·Radiology

AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Freedom Posterior Cervical Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

AMYLASE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BURETTE-IN LINE (150 ML)

FDA 510(k)

FDA Class 2 ·General Hospital