MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING

FDA 510(k)

FDA Class 2 ·General Hospital

ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)

FDA 510(k)

FDA Class 2 ·Ophthalmic

FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TECNOL LASER SURGICAL MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HIGH FILTRATION ISO-MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TECNOL BODY HOLDER

FDA 510(k)

FDA Class 1 ·General Hospital

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·VITREON INTRAOCULAR FLUID (PERFLUOROPERHYDROPHENANTHRENE)

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·VITREON(R)

SEVOFLURANE VAPORIZER ADAPTOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LENEFILCON A HYDROPHILIC CONTACT LENSES

Osstem Italia Srl

Importer

🇮🇹 Italy·5 Manufacturers

Productlife Italy S.r.l

Authorized representative

🇮🇹 Italy·1 Manufacturer

Tandem Diabetes Care Europe B.V.

Importer

🇳🇱 Netherlands·1 Manufacturer

Bayer Medical Care B.V.

Authorized representative

🇳🇱 Netherlands·2 Manufacturers

Abbott Diagnostics GmbH

Importer

🇩🇪 Germany·6 Manufacturers

HD 2014410-1

Certificate

MDD Annex II (excluding section 4)·AIR WATER REALIZE INC.·TÜV Rheinland LGA Products GmbH·55 Basic UDI-DIs

Bayer Medical Care B.V.

Importer

🇳🇱 Netherlands·2 Manufacturers

AMO Ireland

Authorized representative

🇮🇪 Ireland·4 Manufacturers

Tandem Diabetes Care, Inc.

System producer

🇺🇸 United States