Medical Device Manufacturer · US , Walker , MI

Myocure, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1982

15

Total

15

Cleared

0

Denied

FDA 510(k) Regulatory Record - Myocure, Inc. Ophthalmic ✕

12 devices

1-12 of 12

Cleared May 03, 1988

CYSTOTOMES/KNIFES

Ophthalmic · 98d

Cleared May 03, 1988

Ophthalmic · 98d

Cleared May 03, 1988

ANESTHESIA/RETROBULBAR NEEDLES

Ophthalmic · 98d

Cleared Dec 23, 1987

OPHTHALMIC TIP & BLADE SCALPELS

Ophthalmic · 79d

Cleared Dec 22, 1987

OPHTHALMIC DISPOSABLE BLADES

Ophthalmic · 78d

Cleared Sep 21, 1987

OPHTHALMIC PHACO-BLADE

Ophthalmic · 28d

Cleared Oct 20, 1986

OPHTHALMIC SURGICAL DRAPE

Ophthalmic · 32d

Cleared Oct 20, 1986

OPHTHALMIC SURGICAL OCULAR MARKERS

Ophthalmic · 32d

Cleared Oct 20, 1986

Ophthalmic · 32d

Cleared Sep 25, 1986

OPHTHALMIC SURGICAL SPECULUM

Ophthalmic · 7d

Cleared Sep 25, 1986

Ophthalmic · 7d

Cleared Nov 04, 1985

OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE

Ophthalmic · 69d