Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)

FDA 510(k)

FDA Class 2 ·Dental

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

UROSTYM BIOFEEDBACK AND STIMULATION PROBES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR

FDA 510(k)

FDA Class 2 ·Radiology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·FULL FIELD DIGITAL MAMMOGRAPHY

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·KONTUR SOFT (METHAFILCON A) CONTACT LNS

ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS

FDA 510(k)

FDA Class 2 ·Dental

Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System

FDA 510(k)

FDA Class 2 ·Orthopedic

LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)

FDA 510(k)

FDA Class 2 ·Orthopedic

LDR SPINE ROI-T SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BF+

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO EASYSPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LDR SPINE ROI-A IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

EASYSPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BF+ (PH)

FDA 510(k)

FDA Class 2 ·Orthopedic

LDR SPINE ROI-A INTERBODY FUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ROI-C Titanium-Coated Implant System

FDA 510(k)

FDA Class 2 ·Orthopedic