Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IOLAB BRAND MODEL 2192 KELMAN UVBLOC PLUS (LC) UV-ABSORBING PMMA AC IOLS

Orthana GmbH

Importer

🇩🇪 Germany·12 Manufacturers

24 0237 QR/NB

Certificate

MDR QMS·VINAMET CZ s.r.o.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IOLAB BRAND MODEL U85J UVBLOC PLUS (LC) UV-ABSORBING ONE-PIECE FLEXIBLE AC IOLS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CROSS FLEX LC BALLOON-EXPANDABLE STENT WITH OVER THE WIRE DELIVERY SYSTEM FOR CORONARY ARTERIES

Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

FDA classification

FDA Class 2 ·Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Momentum LC

Authorized representative

🇫🇷 France

Defib Deutschland GmbH

Importer

🇩🇪 Germany·1 Manufacturer

LHL, Landsforeningen for hjerte og lungesyke

Importer

🇳🇴 Norway·1 Manufacturer

Medizon B.V.

Importer

🇳🇱 Netherlands·1 Manufacturer

LABORATOIRE DE CONTACTOLOGIE APPLIQUEE - LCA

System producer

🇫🇷 France

2021-MDD/QS-022

Certificate

MDD Annex II (excluding section 4)·OR-CZ spol. s r.o.·3EC International a.s.·1 Basic UDI-DI

Galdent CZ s.r.o.

Authorized representative

🇨🇿 Czechia·1 Manufacturer

BORGY CZ, a.s.

Importer

🇨🇿 Czechia

CANDE CZ s.r.o.

Importer

🇨🇿 Czechia·1 Manufacturer

IMMOMEDICAL CZ s.r.o.

Importer

🇨🇿 Czechia

PHARMAGEN CZ s.r.o.

Importer

🇨🇿 Czechia

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM