Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Control Material, Her-2/Neu, Immunohistochemistry

FDA classification

FDA Class 2 ·Control Material, Her-2/Neu, Immunohistochemistry

System, Test, Her-2/Neu, Monitoring

FDA classification

FDA Class 2 ·System, Test, Her-2/Neu, Monitoring

Kit, Test, Olfactory

FDA classification

FDA Class 2 ·Kit, Test, Olfactory

VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)

FDA 510(k)

FDA Class 2 ·Dental

DiaFil Flow

FDA 510(k)

FDA Class 2 ·Dental

DermaV Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ARIX Clavicle System

FDA 510(k)

FDA Class 2 ·Orthopedic

Finexel

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Nexpowder

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BLUEDIAMOND IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU

FDA 510(k)

FDA Class 2 ·Orthopedic

GBR system

FDA 510(k)

FDA Class 2 ·Dental

14HK701G-W

FDA 510(k)

FDA Class 2 ·Radiology

INNOVERSE Navigation Instruments

FDA 510(k)

FDA Class 2 ·Neurology

Ez3D-i / E3

FDA 510(k)

FDA Class 2 ·Radiology

Perfit ZR HT Dental Zirconia blank

FDA 510(k)

FDA Class 2 ·Dental

Powered Breast Pump (Models 7V and 7X)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Cardio10

FDA 510(k)

FDA Class 2 ·Cardiovascular

RSM 2430C

FDA 510(k)

FDA Class 2 ·Radiology