PHAKO KIT

FDA 510(k)

FDA Class 2 ·Ophthalmic

VXTRA BACK PACK EKG ELECTRODE CAT. NO.

FDA 510(k)

FDA Class 2 ·Cardiovascular

IRRIGATION/ASPIRATION KIT

FDA 510(k)

FDA Class 2 ·Ophthalmic

MICROSURGICAL KNIFE

FDA 510(k)

FDA Class 1 ·Ophthalmic

ADJUSTABLE MICROSURGICAL KNIFE

FDA 510(k)

FDA Class 1 ·Ophthalmic

VXTRA OCUTOME KIT

FDA 510(k)

FDA Class 2 ·Ophthalmic

MICROSURGICAL BLADE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

OCUTOME PARATUBING SET

FDA 510(k)

DISPOSABLE PRE-GELLED ELECTROSURGICAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MICRO BLADE II

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

AMER. SURGICAL CORP. EXTRA PLUS PAK

FDA 510(k)

FDA Class 2 ·Ophthalmic

EXTRACORP.'S INTERSEPT CUS. TUBING PK.

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rivero Extra Grip Femoral Head Remover (Corp)

Device

EU MDR · Eu Md Class 1 ·Innomed, Inc.·On the market

HANDPIECE SYSTEM I/A

FDA 510(k)

FDA Class 1 ·Ophthalmic

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotablator or ROTAPRO Rotational Atherectomy System

EXTRACORPEAL CARDIOTOMY BLOOD FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM