GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Glide Intermittent Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

2GC HIP/KNEE MODULAR SPACER

FDA 510(k)

FDA Class 2 ·Orthopedic

AGC V2 REVISION KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LIFESYS PACS

FDA 510(k)

FDA Class 2 ·Radiology

NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC)

FDA 510(k)

FDA Class 2 ·Orthopedic

AGC AND MAXIM KNEE COMPONENTS WITH NTS

FDA 510(k)

FDA Class 2 ·Orthopedic

BIO-COORDINATOR SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PATIENT SUPPORT SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

REJOYN PENILE SUPPORT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AER-O-SCOPE COLONOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE-EASE TM 2501

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE-EASE MODEL 3500

MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01

FDA 510(k)

FDA Class 2 ·Microbiology

EZ COMPLEMENT C1

FDA 510(k)

FDA Class 2 ·Immunology

FLUORESCENT ANTI. ANTI-HUMAN C3

FDA 510(k)

FDA Class 2 ·Immunology