ACCULASER PRO4

FDA 510(k)

FDA Class 2 ·Physical Medicine

PATIENT MONITORS VARIOUS MODELS

FDA 510(k)

FDA Class 2 ·Cardiovascular

JGH1 Bone Graft Substitute

FDA 510(k)

FDA Class 2 ·Orthopedic

Televere Digital Dental Imaging System

FDA 510(k)

FDA Class 2 ·Dental

CPM System

FDA 510(k)

FDA Class 2 ·Cardiovascular

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

FDA 510(k)

FDA Class 2 ·Hematology

PULPDENT CAVITY PREPARATION III

FDA 510(k)

FDA Class 2 ·Dental

HEMAGEN ENA SM KIT (EIA METHOD)

FDA 510(k)

FDA Class 2 ·Immunology

K-2 TENS OR MED TENS

FDA 510(k)

FDA Class 2 ·Neurology

ESOPHAGEAL BALLOON DILATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACTERA™ hip system

FDA 510(k)

FDA Class 2 ·Orthopedic

T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System

FDA 510(k)

FDA Class 2 ·Orthopedic

CODMAN SKULL CLAMP

FDA 510(k)

FDA Class 2 ·Neurology

STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE

FDA 510(k)

FDA Class 2 ·Radiology

SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

PRODIGY AND PRODIGY PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEAR BRAVO

FDA 510(k)

FDA Class 2 ·Dental

A-CIFT SoloFuse

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)

FDA 510(k)

FDA Class 2 ·General Hospital