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

syngo.CT View&GO

FDA 510(k)

FDA Class 2 ·Radiology

LumenaTM Ureteral Access Sheath

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES

TOMi Scope

FDA 510(k)

FDA Class 2 ·Radiology

OtoSight Middle Ear Scope

FDA 510(k)

FDA Class 2 ·Radiology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE DS AND ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEMS

EP-TRACER System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

FDA Pre-Market Approval

FDA Class 2 ·CILCO ND:YAG LASER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC QUANTUM APEX MONORAIL AND OVER-THE-WIRE PTCA CATHETERS

VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL

FDA 510(k)

FDA Class 2 ·General Hospital

COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;

FDA 510(k)

FDA Class 2 ·Neurology

Bladder Scanner, Model Name:M5

FDA 510(k)

FDA Class 2 ·Radiology

Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)

FDA 510(k)

FDA Class 2 ·Radiology