D. R. MEDICAL CONTROLLED PRESSURE GARMENTS

FDA 510(k)

FDA Class 2 ·General Hospital

DURETTE OCULAR IMPLANT

FDA 510(k)

FDA Class 2 ·Ophthalmic

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur® HBcT2 Quality Control (HBcT2 QC)

BCM 400CP

FDA 510(k)

FDA Class 2 ·Radiology

BCM-400C

FDA 510(k)

FDA Class 2 ·Radiology

ARC-600

FDA 510(k)

FDA Class 2 ·Radiology

BCM-ARC 105 X-RAY MOBILE UNIT

FDA 510(k)

FDA Class 2 ·Radiology

BCM-600TX

FDA 510(k)

FDA Class 2 ·Radiology

SPINOSCOPE

FDA 510(k)

FDA Class 2 ·Physical Medicine

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD PREPSTAIN SYSTEM

AescuLink Software V1.21

Basic UDI-DI

EU MDD · Eu Md Class 2b ·GHC Global Health Care GmbH·1 device

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC)

TUF-COAT

FDA 510(k)

FDA Class 2 ·Dental

G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER

FDA 510(k)

FDA Class 2 ·Dental

UNIFAST LC

FDA 510(k)

FDA Class 2 ·Dental

FUJI LINING CEMENT LIGHT CURE

FDA 510(k)

FDA Class 2 ·Dental

MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES

FDA 510(k)

FDA Class 2 ·Dental

RESUBMITTED EMA DENTIN CEMENT

FDA 510(k)

FDA Class 2 ·Dental

76 ELW BITE CHECKER SILICONE

FDA 510(k)

FDA Class 2 ·Dental