DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VITROS BRAHMS PCT Reagent Pack and Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

B.R.A.H.M.S PCT sensitive KRYPTOR

FDA 510(k)

FDA Class 2 ·Microbiology

VIDAS B.R.A.H.M.S. PCT (PCT)

FDA 510(k)

FDA Class 2 ·Microbiology

Atellica IM BRAHMS Procalcitonin (PCT)

FDA 510(k)

FDA Class 2 ·Microbiology

Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

FDA 510(k)

FDA Class 2 ·Microbiology

ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

CARDIO REP LD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REP ALP-15, 8, & 4 KITS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

P.R.G. PERCUTANEOUS REPLACEMENT GASTROSTOMY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ANGEFLATOR(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMNIFIT II EPF HIP STEM SERIES

FDA 510(k)

FDA Class 2 ·Orthopedic

DIABETES RISK DETECTOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RF-1 CIRCUIT

FDA 510(k)

FDA Class 2 ·Radiology

SPIFE IFE-6

FDA 510(k)

FDA Class 2 ·Immunology

AIDE-A-PATIENT (NURSING HOME BED)

FDA 510(k)

FDA Class 2 ·General Hospital