AIRCAST VENAFLOW ELITE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

OC-Light S FIT

FDA 510(k)

FDA Class 2 ·Hematology

HANNIBAL GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAREVENT ATV+ AND CAREVENT MRI

FDA 510(k)

FDA Class 2 ·Anesthesiology

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY Elite Aortic Valve

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards pericardial Mitral Bioprosthesis and Edwards INSPIRIS RESILIA Aortic V

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PE

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

ArcTV™ Transvaginal Sling System

FDA UDI

UROCURE LLC·00860368002401·ArcTV™ Transvaginal Sling System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW AND OTE LV LEAD

RF1 Nebulizer w/ATV, 1.6M Tube

Device

EU MDR · Eu Md Class 2a ·GaleMed Corporation·On the market·1 country

OLV VISICTYN+ TRAY OSTEOTECH NO LASER

Device

EU MDR · Eu Md Class 1 ·Ippi srl·On the market

LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST/VIRTUOSO/VIRTUOSO II/MAXIMO/MAXIMO II/SECURA/MARQUIS/INSTRINSIC 35J ICDS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL ELASTIC/ELASTIMIDE/ELASTIC TORIC/ASPHERIC ELASTIMIDE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR

FDA Pre-Market Approval

MAXIMO II CRT-D/CONCERTO ICD/CONSULTA CRT-D/INSYNC III MARQUIS/PROTECT/INSYNC SENTRY ICD/CONCERTO II CRT-D

CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK

FDA 510(k)

FDA Class 2 ·Dental

PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S

FDA 510(k)

FDA Class 2 ·Dental

PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S

FDA 510(k)

FDA Class 2 ·Dental