PREMIUM - SHELTA Prosthetic Components

FDA 510(k)

FDA Class 2 ·Dental

DRF 4343

FDA 510(k)

FDA Class 2 ·Radiology

AutoStrut

FDA 510(k)

FDA Class 2 ·Orthopedic

ReadeR, VieweR, QuickScan PSP

FDA 510(k)

FDA Class 2 ·Dental

COR ANALYZER

FDA 510(k)

FDA Class 2 ·Radiology

PROLINK ADHESIVES (PROLINK, PROLINK SE)

FDA 510(k)

FDA Class 2 ·Dental

Novidia Flowable Composite

FDA 510(k)

FDA Class 2 ·Dental

STOP U (Packed Black USA), STOP U (Packed White USA)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MINIMA S System

FDA 510(k)

FDA Class 2 ·Orthopedic

PARENTERAL ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·General Hospital

D-SPECT Scanner, D-SPECT L Scanner

FDA 510(k)

FDA Class 2 ·Radiology

ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)

FDA 510(k)

FDA Class 2 ·Ophthalmic

GIVEN DIAGNOSTICS SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BriefCase

FDA 510(k)

FDA Class 2 ·Radiology

PREMIUM, SHELTA Implant Systems

FDA 510(k)

FDA Class 2 ·Dental

BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISPOSABLE ADHESIVE SURFACE ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

MRopen EVO

FDA 510(k)

FDA Class 2 ·Radiology

SENTINEL LITHIUM ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology