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Panels › Ophthalmic › Product code HNN · Class 1

Knife, Ophthalmic

Regulation 886.4350

0510(k)s in 12 months (54 all time)

1recalls in 12 months (155 all time)

14recalls that name a 510(k)

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Top companies in HNN

Company	510(k)s	Recalls
Bausch & Lomb Inc Irb	0	46
Oasis Medical Inc	0	36
Alcon Research, Ltd.	1	27
Becton Dickinson and Company	0	11
Surgical Specialties Puerto Rico, Inc.	0	7
Tecfen Medical	0	7
Beaver Visitec International, Inc.	0	6
Alcon Laboratories, Inc	0	5
Myocure, Inc.	5	0
Keeler Instruments, Inc.	4	0

Date	Firm and product	Code	Linked 510(k)
Jul 20, 2004	Surgical Specialties Puerto Rico, Inc. Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm and 56-5161, Pilot Tip Knife, bevel up, angled, full handled, 5.2mm Terminated	HNN	K822112
Jul 20, 2004	Surgical Specialties Puerto Rico, Inc. Stylus Angled Knife - 52-2835 Clear Corneal Knife, double bevel, parallel sides, angled, full handle, 2.85mm Terminated	HNN	K822112
Oct 15, 2003	Surgical Specialties Corp Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives. Terminated	HNN	K822112
Jun 5, 2003	Surgical Specialties Puerto Rico, Inc. 2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus * 2.75 mm Slit Knife Angled, Bevel, UpOne Unit STERILE R DisposableSurgical Specialties CorporationReading, PA 19606**'' Terminated	HNN	K822112
Apr 1, 2003	Surgical Specialties Corp Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm. Terminated	HNN	K822112

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