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

OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FORMASURE TEST REAGENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SCHNEIDER MATCH-35(TM) PERCU TRANS ANGIOPLAS CATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

SWELL-RELIEF

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMPAT ENTERAL DELIVERY SYSTEMS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Amplatz Goose Neck Snare Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS

FDA 510(k)

FDA Class 2 ·Microbiology