BIOTRACE-N, NS, 410 AND RT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECOTABS

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTIS Metallic Stent Optimization E.4 SW

FDA 510(k)

FDA Class 2 ·Radiology

BLOOD OXYGENATORS #BOS-105S BOS-5S W/

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLYCOMAT HAEMOGLOBIN ANALYSER

FDA 510(k)

FDA Class 2 ·Hematology

GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT

FDA 510(k)

FDA Class 2 ·Hematology

745 GLYCOMAT

FDA 510(k)

FDA Class 2 ·Hematology

I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BARBITURATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIASTAT ANTI-SM/RNP

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-LA (SS-B)

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-RO (SS-A)

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-SM

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ENA PROFILE

FDA 510(k)

FDA Class 2 ·Immunology

REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE

FDA 510(k)

FDA Class 2 ·Orthopedic

RHYTHMSTAR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMPAT ENTERAL DELIVERY PUMP SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SLEEP TEST(TM)

FDA 510(k)

FDA Class 2 ·Anesthesiology

INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1

FDA 510(k)

FDA Class 2 ·Cardiovascular

COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1

FDA 510(k)

FDA Class 2 ·Cardiovascular