AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Ultrasound, Cyclodestructive

FDA Pre-Market Approval

FDA Class 2 ·THERAPEUTIC ULTRASOUND FOR TREATMENT OF GLAUCOMA

ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Monkey Bars Pin to Bar External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

FDA 510(k)

FDA Class 2 ·Medical Genetics

R-BAR RETRACTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BARS Set (100.60)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CAM STRUCTSURE BARS

FDA 510(k)

FDA Class 2 ·Dental

DENTAL ARCH BAR

FDA 510(k)

FDA Class 2 ·Dental

CUTANEOUS (BAR) ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

SFI BAR ABUTMENTS

FDA 510(k)

FDA Class 2 ·Dental

ACUFEX T-BAR

FDA 510(k)

FDA Class 2 ·Orthopedic

NOBELPROCERA OVERDENTURE BAR

FDA 510(k)

FDA Class 2 ·Dental

DEFI 2

FDA 510(k)

FDA Class 2 ·Cardiovascular

THE UNIVERSAL CEMENT PLUG(TM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRAUMACAD 1.2

FDA 510(k)

FDA Class 2 ·Radiology

LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586

FDA 510(k)

FDA Class 2 ·Dental

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Medical Genetics