OIC

FDA UDI

Provision·B504OMDR251100·

OIC

FDA UDI

Provision·B504OMDR33110C0·

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATOMED SILICONE OIL OP5000

ACRYTOL, MOUNTING MEDIUM

FDA 510(k)

FDA Class 1 ·Pathology

CLEARIUM, MOUNTING MEDIUM

FDA 510(k)

FDA Class 1 ·Pathology

ENTELLAN

FDA 510(k)

FDA Class 1 ·Pathology

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current, Fortify, Fortify Assura, Ellipse

FLU OIA A/B TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

OIC Small / Mini Fragment Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

Torosa

FDA UDI

Coloplast A/S·05708932470858·Saline Filled Testicular Prosthesis

Torosa

FDA UDI

Coloplast A/S·05708932470797·Saline Filled Testicular Prosthesis

Torosa

FDA UDI

Coloplast A/S·05708932470810·Saline Filled Testicular Prosthesis

Torosa

FDA UDI

Coloplast A/S·05708932470834·Saline Filled Testicular Prosthesis

SnapshotNIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

iLet® Dosing Decision Software

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

InVision™ 1.5 Surgical Theatre

FDA 510(k)

FDA Class 2 ·Radiology

EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS

FDA 510(k)

FDA Class 2 ·Orthopedic

Exactech Alteon Modular Dual Mobility (MDM) System

FDA 510(k)

FDA Class 2 ·Orthopedic

iLet® ACE Pump

FDA 510(k)

FDA Class 2 ·Clinical Chemistry