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

LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

PERFECTA PDA TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MitraClip G4 Steerable Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

NK GRASP SENSOR, MODEL GR001

FDA 510(k)

FDA Class 2 ·Orthopedic

EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS

FDA 510(k)

FDA Class 2 ·Immunology

DUALSCREEN

FDA 510(k)

FDA Class 2 ·Neurology

R&D BATTEERIES, INC. PART NUMBERS 5173, 5178, 5197 AND 5199

FDA 510(k)

FDA Class 2 ·General Hospital