PMT Platinum Depthalon Depth Electrode

FDA 510(k)

FDA Class 2 ·Neurology

Duo Lumbar Interbody Fusion Device

FDA 510(k)

FDA Class 2 ·Orthopedic

QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP

FDA 510(k)

FDA Class 2 ·Microbiology

MEDTRONIC MODEL 3586 RESUME LEAD

FDA 510(k)

FDA Class 2 ·Neurology

TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAPSET CALCIUM SULFATE BONE GRAFT PLASTER

FDA 510(k)

FDA Class 2 ·Dental

R350 guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

3M X-LARGE SHEET #7979/ #7979NS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BodyGuardian Remote Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCIMED II MEMBRANE OXYGENATOR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

HGB-CAL SET/MULTIPLE

FDA 510(k)

FDA Class 2 ·Hematology

ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209

FDA 510(k)

FDA Class 2 ·Immunology

Bio-Medicus Life Support Catheter and Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

INSORB ABSORBABLE STAPLE, MODEL 1020

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

LOVIEL CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

R&D BATTERIES, PART NOS. 5243, 5104, AND 5481

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry