not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278795724·Software Pristina 8.3 - ISO file

not applicable

FDA UDI

GE MEDICAL SYSTEMS·00195278716026·UDI Software Pristina ME 9.1

CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)

FDA 510(k)

FDA Class 2 ·Dental

KATANA Zirconia

FDA 510(k)

FDA Class 2 ·Dental

KATANA AVENCIA Block

FDA 510(k)

FDA Class 2 ·Dental

CLEARFIL MAJESTY ES Flow

FDA 510(k)

FDA Class 2 ·Dental

CLEARFIL MAJESTY IC

FDA 510(k)

FDA Class 2 ·Dental

PANAVIA SA Cement Universal

FDA 510(k)

FDA Class 2 ·Dental

PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer

FDA 510(k)

FDA Class 2 ·Dental

PANAVIA Veneer LC

FDA 510(k)

FDA Class 2 ·Dental

CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack

FDA 510(k)

FDA Class 2 ·Dental

PANAVIA SA Cement Plus Handmix

FDA 510(k)

FDA Class 2 ·Dental

Eye spray

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Ote Pharma Sol B.V.·1 device

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Selenia Dimensions 3D System.

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·SENOCLAIRE