Obstetrical Kit

FDA classification

FDA Class 2 ·Obstetrical Kit

cobas BKV

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m BKV

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

ONE TRAY® Sealed Sterilization Container System

FDA 510(k)

FDA Class 2 ·General Hospital

EZ-TRAXTM Persona Knee Containment Device

FDA 510(k)

FDA Class 2 ·General Hospital

EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device

FDA 510(k)

FDA Class 2 ·General Hospital

DYNATRON 500

FDA 510(k)

FDA Class 2 ·Physical Medicine

JOSTRA VENT CATHETERS, MODELS LV & HKV

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY

FDA 510(k)

FDA Class 2 ·Neurology

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 151 (PAFLUFOCON D) CLEAR & TINTS W/O UV

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ENVIEW (TM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MANDOMETER III

FDA 510(k)

FDA Class 2 ·Neurology

KSEA ENDOSCOPE HOLDER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOFIX EXO

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KARL STORZ Holders

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

WalterLorenz Surgical Assist Arm Scope Holder

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology