Medical Device Manufacturer · US , Mchenry , IL

Suncoast Medical Manufacturers, Inc. - FDA 510(k) Cleared Devices

31 submissions · 29 cleared · Since 1984

Recent clearances: REPLACE-A-TIP ADJUST. LOW TEMP.-, REPLACE-A-TIP ADJUSTABLE HIGH TEMP., ADJUST-A-TEMP MICRO

31

Total

29

Cleared

0

Denied

FDA 510(k) Regulatory Record - Suncoast Medical Manufacturers, Inc. Ophthalmic ✕

10 devices

1-10 of 10

Cleared May 09, 1984

OPTHERM FINE TIP

Ophthalmic · 99d

Cleared May 09, 1984

OPTHERM EXTRA FINE TIP

Ophthalmic · 99d

Cleared May 09, 1984

SUN-LITE BLUE SPOT

Ophthalmic · 99d

Cleared May 09, 1984

SUN-LITE PEN LIGHT

Ophthalmic · 99d

Cleared May 09, 1984

SUN-LITE WHITE SLIT

Ophthalmic · 99d

Cleared May 09, 1984

REPLACE-A-TIP RECHARG. LOW TEMP.

Ophthalmic · 37d

Cleared May 09, 1984

REPLACE-A-TIP RECHARGEABLE HIGH TEMP

Ophthalmic · 37d

Cleared Apr 23, 1984

SURG A STAT FINE TIP 5

Ophthalmic · 77d

Cleared Apr 13, 1984

SUN-LITE ONE MILLIMETER

Ophthalmic · 73d

Cleared Apr 13, 1984

Ophthalmic · 71d