VITEK 2 GRAM POSITIVE ERTAPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOPSY FORCEPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

NextGen Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFIED PERIPHERAL DILATATION CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

BONE LAVAGE SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Reprocessed Steerable Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITATRACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MONOJECT(R) 6 CC SAFETY SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LAKE MALE EXTERNAL CATHETERIZATION KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pacel Bipolar Pacing Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206

FDA 510(k)

FDA Class 2 ·Immunology

CLARUS ENDOSCOPIC HOOK KNIFE

FDA 510(k)

FDA Class 2 ·Ophthalmic

SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL

FDA 510(k)

FDA Class 2 ·Cardiovascular

R&D BATTERIES PART NOS. 5167, 5221, 5244 AND 5247

FDA 510(k)

FDA Class 2 ·General Hospital

LUX-Dx Insertable Cardiac Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP

FDA 510(k)

FDA Class 2 ·General Hospital