COBAS STANDARDS FOR CALCIUM-IN-ORGANIC

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CUSTOMED CYSTO PACK I

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Air Relax Plus Model AR-3.0

FDA 510(k)

FDA Class 2 ·Physical Medicine

DENTAL PORCELAIN-VARIOUS

FDA 510(k)

FDA Class 2 ·Dental

Air Relax Pro Model AR-4.0

FDA 510(k)

FDA Class 2 ·Physical Medicine

TECHFIT Patient-Specific Maxillofacial System

FDA 510(k)

FDA Class 2 ·Dental

AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

Portux CAD/CAM Disc

FDA 510(k)

FDA Class 2 ·Dental

HEMOCATH I KIDNEY DIALYSIS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COAXIAL DUAL FLOW CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DUAL LUMEN NEEDLES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED DUAL LUMEN NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DUAL LUMEN NEEDLE (PRODUCT CHANGE)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle

FDA 510(k)

FDA Class 2 ·General Hospital

SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]

FDA 510(k)

FDA Class 2 ·Cardiovascular

CUSTOMED CYSTO PACK II

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CUSTOMED BASIC PACK II

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CUSTOMED BASIC PACK I

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CUSTOMED ORTHOPEDIC II

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CUSTOMED BASIC PACK III

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery