Atlas FDA

HNN

54 FDA 510(k) clearances · Product code

33 daysmedian time to decision
125 days90th percentile
54clearances measured

FDA profile

Official device name
Knife, Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.4350
Medical specialty
Ophthalmic
Adverse events (MAUDE)
2021: 403 · 2022: 327 · 2023: 355 · 2024: 1,844 · 2025: 701 · 2026: 379
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
CLEARCUT S SAFETY KNIFE (K110166)Alcon Research, Ltd.2011-05-20
OPHTHALMIC KNIFE (K922378)Microptics Development Laboratory1992-12-10
RETRACTIVE INCISION MICROMETER (RIM) GUAGE (K882402)Optical Center1988-08-22
MVR/STILETTO BLADE 20GA. - P/N 1900 (K881669)Advanced Surgical Products, Inc.1988-05-13
PRISMA DISPOSABLE MVR/STILETTO BLADE (K874979)Advanced Surgical Products, Inc.1988-04-13
OPHTHALMIC TIP & BLADE SCALPELS (K874057)Myocure, Inc.1987-12-23
OPHTHALMIC DISPOSABLE BLADES (K874056)Myocure, Inc.1987-12-22
OPHTHALMIC PHACO-BLADE (K873385)Myocure, Inc.1987-09-21
KNIFE, OPHTHALMIC (K871285)Trueline Instruments, Inc.1987-04-27
RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE (K864290)Keeler Instruments, Inc.1986-12-15
CATARACT DIAMOND KNIFE (K863725)Medical Technology Development Corp.1986-10-31
THE ULTIMATE (K863665)Myocure, Inc.1986-09-25
SAPPHIRE KNIFE BLADE (K861744)Keeler Instruments, Inc.1986-06-09
RUBY & SAPPHIRE BLADE HOLDER (K861748)Keeler Instruments, Inc.1986-06-02
ROPHAE DIAMOND KNIFE (K861491)Rophae Lens Co., Inc.1986-05-28
STORZ E9050 & E9055 DIAMOND KNIVES (K861732)Storz Instrument Co.1986-05-28
CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE (K861334)Cilco, Inc.1986-05-02
SAPPHIRE BLADE SURGICAL KNIFE (K860852)Med-Tech Develoment Corp.1986-03-28
STORZ E9040 & E9046 DIAMOND KNIVES (K855050)Storz Instrument Co.1986-03-05
DIAMOND BLADE MICROMETER KNIFE (K860332)Med-Tech Develoment Corp.1986-02-13
DISPOSABLE SURGICAL KNIFE (K860331)Med-Tech Develoment Corp.1986-02-12
BEAVER MICRO-GEM GAUGE BLOCK (K860305)Rudolph Beaver, Inc.1986-02-12
OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE (K853598)Myocure, Inc.1985-11-04
VERSABLADE (K852706)Alphamedix, Inc.1985-11-04
BEAVER R-K KNIFE (K852828)Rudolph Beaver, Inc.1985-11-04
STORZ DIAMOND KNIFE (K853403)Storz Instrument Co.1985-11-04
SMARTKNIFE SYSTEM (K853063)CooperVision, Inc.1985-11-04
VERSABLADE (K852633)Alphamedix, Inc.1985-11-04
MICRON-SCOPE (K853499)Magnum Diamond, Inc.1985-09-24
BEAVER MULTIPURPOSE SAPPHIRE KNIFE (K853129)Rudolph Beaver, Inc.1985-08-06
37-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN (K851790)Artiberia1985-05-23
CATARACT TRAY (K842647)Deroyal Industries, Inc.1985-05-09
KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA (K850049)Xtal Corp.1985-03-06
MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE (K844553)Codman & Shurtleff, Inc.1984-12-11
CILCO DIAMOND KNIFE (K843447)Cilco, Inc.1984-10-05
MICROSURGICAL KNIFE (K841951)ETHICON, Inc.1984-06-01
CORNEAL SCLERAL LANCE (K840855)Sharpoint, Inc.1984-05-09
SURGICAL KNIFE (K834546)Fine-Cut Diamond Instruments1984-03-16
RUBY KNIVES FOR OPHTH. SURGERY (K832844)Keeler Instruments, Inc.1983-09-29
LEADING EDGE OPHTHALMIC KNIFE (K831975)Surgidev Corp.1983-08-31
MICROSURGICAL KNIFE (K831266)Vxtra Corp.1983-06-10
DIAMOND KNIFE (K830366)Koi, Inc.1983-03-09
OPHTHALMIC KNIFE (K822112)Sharpoint, Inc.1982-08-10
V LANCE (K821440)Sharpoint, Inc.1982-06-14
MICROSURGERY KNIFE (K820618)Visitec Co.1982-04-09
PILLING K KNIFE (K812918)Narco Scientific1981-11-06
ADJUSTABLE MICROSURGICAL KNIFE (K812620)Vxtra Corp.1981-10-19
KOI DIAMOND KNIFE (K812450)Koi, Inc.1981-09-21
SWAN KNIFE NEEDLE 1.5MM CAT # 1170 (K791981)Edward Weck, Inc.1979-10-04
TOME'S #'S 1221,1222,1223,1314,6640,6642 (K791980)Edward Weck, Inc.1979-10-04
MICROSURGICAL KNIVES, 20, 30, 45 (K781465)Codman & Shurtleff, Inc.1978-09-20
DISSECTOR, TROUTMAN CORNEAL (K760186)V. Mueller O.V. Baxter Healthcare Corp.1976-08-04
KNIFE, TROUTMAN CORNEAL LARGE (K760191)V. Mueller O.V. Baxter Healthcare Corp.1976-08-04
KNIFE, TROUTMAN CORNEAL SMALL (K760187)V. Mueller O.V. Baxter Healthcare Corp.1976-08-04

Track HNN automatically

Every clearance here is in the API, with alerts when new ones post.