Medical Device Manufacturer · US , Sudbury , MA

G.W.B. Intl., Ltd. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1990

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - G.W.B. Intl., Ltd. Ophthalmic ✕

7 devices

1-7 of 7

Cleared Mar 06, 1996

RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)

Ophthalmic · 93d

Cleared Oct 05, 1995

OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)

Ophthalmic · 42d

Cleared Mar 14, 1995

OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}

Ophthalmic · 41d

Cleared May 04, 1994

OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)

Ophthalmic · 89d

Cleared Jun 18, 1991

OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS

Ophthalmic · 106d

Cleared May 13, 1991

OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS

Ophthalmic · 70d

Cleared May 01, 1991

OPHTA SIL (R), LACHRYMAL INTUBATION SETS

Ophthalmic · 58d