76 ELW BITE CHECKER SILICONE

FDA 510(k)

FDA Class 2 ·Dental

EXAMIX DISPENSER

FDA 510(k)

FDA Class 1 ·Dental

TOOTH SHADE RESIN

FDA 510(k)

FDA Class 2 ·Dental

LIMI ALLOY

FDA 510(k)

FDA Class 2 ·Dental

DENTURE RESIN

FDA 510(k)

FDA Class 2 ·Dental

G-CERA PORCELAIN BOND

FDA 510(k)

FDA Class 2 ·Dental

EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL

FDA 510(k)

FDA Class 2 ·Radiology

GC CERVICAL CEMENT

FDA 510(k)

FDA Class 2 ·Dental

FUJI II LC

FDA 510(k)

FDA Class 2 ·Dental

76 EMA LINING CEMENT

FDA 510(k)

FDA Class 2 ·Dental

SURFLEX F

FDA 510(k)

FDA Class 2 ·Dental

FUJI CAP II CAPSULE & APPLIER

FDA 510(k)

FDA Class 2 ·Dental

GCE, s.r.o.

Authorized representative

🇨🇿 Czechia·1 Manufacturer

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR(R)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(TM)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotablator™and ROTAPRO™ Rotational Atherectomy System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(R) SCA-I(TM),SCA-LP(TM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·AngioJet Rheolytic Thrombectomy Catheter

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotablator® Rotational Atherectomy System