Stealthstation S8 System Platforms and StealthStation Cranial Software

FDA registration

MEDTRONIC NAVIGATION, INC.·3 products·🇺🇸 United States

Schneider ASR B.V.

FDA registration

Schneider ASR B.V.·2 products·🇳🇱 Netherlands

MIDAS REX CURVED BUR

FDA registration

Sterigenics US LLC·2 products·🇺🇸 United States

Midas Rex Curved Burs

FDA registration

MEDTRONIC XOMED, INC.·2 products·🇺🇸 United States

OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

MICRO-EAR LOW-PROFILE IN-THE-EAR HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-38 (POLYMACON)

FDA 510(k)

FDA Class 2 ·Ophthalmic

MICRO-EAR CANAL IN-THE-EAR HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT

FDA 510(k)

FDA Class 2 ·Ophthalmic

BOSTON KERATOPROSTHESIS OR BOSTON KPRO

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT)

FDA 510(k)

FDA Class 2 ·Ophthalmic

MICRO-EAR FULL-CONCHA IN-THE-EAR HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

IN-THE-EAR-CANAL HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve