510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HNRClass I

Forceps, Ophthalmic

21 CFR 886.4350 / Ophthalmic
FDA source (opens on fda.gov)

HNR is the FDA product code for Forceps, Ophthalmic, a class I device type, regulated under 21 CFR 886.4350. As of , FDA records hold 44 510(k) clearances under this code, the most recent dated , and 16 recalls.

Classification record

Product code
HNR
Device name
Forceps, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
44
Ingested recalls
16

Clearances, product code HNR

By decision year
44 clearances under product code HNR with a decision year between 1976 and 2002, 1986 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code HNR by decision year
YearClearances
19762
19778
19791
19803
19812
19821
19844
19854
198611
19883
19894
20021

Applicants with the most clearances

Product code HNR
Applicants holding the most 510(k) clearances under product code HNR
ApplicantClearances
Edward Weck, Inc.14
Alcon Laboratories2
Artiberia2
Keeler Instruments, Inc.2
Storz Instrument Co.2
Western Medical Products, Inc.2
Advanced Surgical Products, Inc.1
Advanced Medical Optics, Inc.1
Allergan1
American Pharmaseal Div. Ahsc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 260 companies shown, in name order