ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ISENS

FDA registration

VISION SCIENCE CO., LTD.·2 products·🇰🇷 South Korea

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·METHAFILCON A AND METHAFILCON B SOFT HYDROPHILIC WEAR CONTACT LENSES INSTALLATION AND VALIDATION OF A NEW 3M ATTEST 290

PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Axiom

FDA UDI

ETABLISSEMENTS ANTHOGYR·03663394000024·Implant Ø2.8 x 10 mm Replacement of a missing t...

Axiom

FDA UDI

ETABLISSEMENTS ANTHOGYR·03663394000215·AXIOM IMPLANT Ø4.6 x 12.0 Replacement of a miss...

Axiom

FDA UDI

ETABLISSEMENTS ANTHOGYR·03663394000260·AXIOM IMPLANT Ø5.2 x 12.0 Replacement of a miss...

Axiom

FDA UDI

ETABLISSEMENTS ANTHOGYR·03663394000239·AXIOM IMPLANT Ø5.2 x 6.5 Replacement of a missi...

Axiom

FDA UDI

ETABLISSEMENTS ANTHOGYR·03663394000185·AXIOM IMPLANT Ø4.6 x 6.5 Replacement of a missi...

Axiom

FDA UDI

ETABLISSEMENTS ANTHOGYR·03663394000192·AXIOM IMPLANT Ø4.6 x 8.0 Replacement of a missi...

Axiom

FDA UDI

ETABLISSEMENTS ANTHOGYR·03663394000093·AXIOM IMPLANT Ø3.4 x 16.0 Replacement of a miss...

Axiom

FDA UDI

ETABLISSEMENTS ANTHOGYR·03663394000116·AXIOM IMPLANT Ø4.0 x 6.5 Replacement of a missi...

Axiom

FDA UDI

ETABLISSEMENTS ANTHOGYR·03663394000161·AXIOM IMPLANT Ø4.0 x 16.0 Replacement of a miss...

Axiom

FDA UDI

ETABLISSEMENTS ANTHOGYR·03663394000147·AXIOM IMPLANT Ø4.0 x 12.0 Replacement of a miss...

Axiom

FDA UDI

ETABLISSEMENTS ANTHOGYR·03663394000109·AXIOM IMPLANT Ø3.4 x 18.0 Replacement of a miss...

Axiom

FDA UDI

ETABLISSEMENTS ANTHOGYR·03663394000055·AXIOM IMPLANT Ø3.4 x 8.0 Replacement of a missi...

Axiom

FDA UDI

ETABLISSEMENTS ANTHOGYR·03663394000031·Implant Ø2.8 x 12 mm Replacement of a missing t...

Axiom

FDA UDI

ETABLISSEMENTS ANTHOGYR·03663394000062·AXIOM IMPLANT Ø3.4 x 10.0 Replacement of a miss...