HOZ · Class II · 21 CFR 886.4790

FDA Product Code HOZ: Sponge, Ophthalmic

Leading manufacturers include Visitec Co., Ultracell Medical Technologies, Inc. and Jedmed Instrument Co..

47
Total
47
Cleared
100d
Avg days
1976
Since

FDA 510(k) Cleared Sponge, Ophthalmic Devices (Product Code HOZ)

47 devices
1–24 of 47
Cleared Oct 30, 2013
SUNTOUCH EYE SPEAR
K132796
Huizhou Foryou Medical Devices Co., Ltd.
Ophthalmic · 54d
Cleared Oct 29, 2013
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
K130117
Network Medical Products, Ltd.
Ophthalmic · 286d
Cleared Oct 23, 2009
ALPHAMED SURGICAL SPEAR, MODEL 70-5000
K091240
Alphamed, Inc.
Ophthalmic · 179d
Cleared Dec 15, 2008
CENEFOM PVA SURGICAL SPEAR
K082460
Longtek Scientific Co., Ltd.
Ophthalmic · 111d
Cleared Aug 24, 2001
ULTRACELL ABSORBENT STICK
K012196
Ultracell Medical Technologies, Inc.
Ophthalmic · 42d
Cleared Jun 26, 2001
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
K011191
Medtronic Xomed, Inc.
Ophthalmic · 68d
Cleared Apr 13, 2001
PRESCOTT'S SURGICAL SPEAR
K003842
Prescott'S, Inc.
Ophthalmic · 122d
Cleared Aug 18, 2000
ML EYE SPEAR, MODEL ML 27 ES
K002279
Med-Logics, Inc.
Ophthalmic · 23d
Cleared Dec 21, 1999
M-PACT CORNEAL LIGHT SHIELD
K993883
M-Pact Corp.
Ophthalmic · 36d
Cleared May 10, 1999
DRAINAGE WICK
K990671
Hurricane Medical
Ophthalmic · 69d
Cleared Apr 02, 1999
SOF-SUCTION FLUID EVACUATION SYSTEM
K990749
X-Tech Medical, LLC
Ophthalmic · 25d
Cleared Feb 16, 1999
THE FREMSTAD RING
K982599
Ophthalmic Solutions, LLC
Ophthalmic · 204d
Cleared Mar 02, 1998
HYDROFERA SURGICAL SPEAR
K974313
Hydrofera, LLC
Ophthalmic · 105d
Cleared Dec 17, 1997
ULTRACELL SUCTION SPONGE
K972633
Ultracell Medical Technologies, Inc.
Ophthalmic · 156d
Cleared Sep 30, 1997
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
K972693
Deroyal Industries, Inc.
Ophthalmic · 74d
Cleared Jul 31, 1997
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
K971832
M-Pact Worldwide Management Corp.
Ophthalmic · 73d
Cleared Mar 04, 1997
EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
K964855
Shippert Medical Technologies Corp.
Ophthalmic · 90d
Cleared Mar 22, 1995
IVALON OPHTHALMIC SPONGE
K946016
Ivalon
Ophthalmic · 103d
Cleared Feb 27, 1995
OPHTHALMIC SPONGES
K950241
Oasis Medical, Inc.
Ophthalmic · 38d
Cleared Jul 15, 1994
SURGI-WIPE
K942642
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 42d
Cleared Dec 27, 1993
VISI-SPEAR EYE SPONGE
K933872
Visitec Co.
Ophthalmic · 143d
Cleared Mar 19, 1993
SURGICAL SPEARS
K923922
Ultracell Medical Technologies, Inc.
Ophthalmic · 226d
Cleared Aug 05, 1992
OPHTHALMIC SPONGES
K920354
Ultracell Medical Technologies, Inc.
Ophthalmic · 191d
Cleared Apr 10, 1991
OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
K910707
Jedmed Instrument Co.
Ophthalmic · 49d

About Product Code HOZ - Regulatory Context