Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT/ANTI-HBS CALIBRATORS

MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION)

FDA 510(k)

FDA Class 2 ·Orthopedic

GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING

FDA 510(k)

FDA Unclassified ·Unknown

ALLEN UNIVERSAL STIRRUP

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

THE PORTABLE ORDERLY

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

CORNEO-GAGE TWO

FDA 510(k)

FDA Class 2 ·Radiology

BRAIN PERFUSION OPTION

FDA 510(k)

FDA Class 2 ·Radiology

ALLEN PRONE ARMBOARD

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

STAT PAK

FDA 510(k)

FDA Class 1 ·Dental

SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

ALLEN LATERAL ARMBOARD

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

FIAD EXPLOR-X; MODEL 70 KVP

FDA 510(k)

FDA Class 2 ·Dental

PIVOT ASSIST

FDA 510(k)

FDA Class 2 ·Physical Medicine

ACQSIM-MULTISLICE-CT, MODEL 453567042271

FDA 510(k)

FDA Class 2 ·Radiology

MAUNAL DISPOSABLE DENTAL INSTRUMENTS

FDA 510(k)

FDA Class 1 ·Dental

ALLEN MALLEABLE ANESTHESIA SCREEN

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAUZE DRESSING

FDA 510(k)

FDA Unclassified ·Unknown