PRIMUS PSS SERIES STERILIZERS

FDA 510(k)

FDA Class 2 ·General Hospital

NON-LINTING DELIVERY BLANKET

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SURGEON'S GOWN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISINFECTION WITH THE COX DRY HEAT STERILIZER

FDA 510(k)

FDA Class 2 ·General Hospital

DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE

FDA 510(k)

FDA Class 2 ·General Hospital

G.R.A.M. SLIDE

FDA 510(k)

FDA Class 1 ·Microbiology

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·METHAFILCON A SOFT HYDROPHILIC EXTENDED WEAR CONTACT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Multifocal Toric II Intraocular Lenses

BREG

FDA UDI

BREG, INC.·00672736020678·

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VENTRICULAR (VAD) ASSIST DEVICE SYSTEM

Disposable Steel Lancets

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Sterilance Medical (Suzhou) Inc.·2 devices

Safety Scalpel Cartridges

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Sterilance Medical (Suzhou) Inc.·22 devices

Heel Incision Safety Lancets

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Sterilance Medical (Suzhou) Inc.·8 devices

Safety Metal Handles

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Sterilance Medical (Suzhou) Inc.·4 devices

Disposable Skin Prick Lancets

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Sterilance Medical (Suzhou) Inc.·1 device

Disposable Surgical Blades

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Sterilance Medical (Suzhou) Inc.·3 devices

Disposable Blood Lancets

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Sterilance Medical (Suzhou) Inc.·17 devices

Disposable Swabs

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Sterilance Medical (Suzhou) Inc.·1 device

Disposable Safety Lancets

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Sterilance Medical (Suzhou) Inc.·19 devices