PuraSinus

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Spirair Nasal Septal Strap

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INEX Absorbable Nasal Implant

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LATERA Absorbable Nasal Implant System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MACROPORE ENT RECONSTRUCTION FILM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MEROGEL INJECTABLE BIORESORBABLE STENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Latera Absorbable Nasal Implant

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SPIROX INEX DEVICE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NASOPORE EAR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PDS PLATES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·BOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A)

Balloon Inflation System

FDA 510(k)

FDA Class 2 ·Orthopedic

TOMi Scope

FDA 510(k)

FDA Class 2 ·Radiology

OtoSight Middle Ear Scope

FDA 510(k)

FDA Class 2 ·Radiology

MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·UNPRESERVED CONSEPT-2 RINSING & NEUTRALIZING SOL.

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital