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

Instrument, Measuring, Corneal Radius

21 CFR 886.1450 / Ophthalmic
FDA source (opens on fda.gov)

HJB is the FDA product code for Instrument, Measuring, Corneal Radius, a class I device type, regulated under 21 CFR 886.1450. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
HJB
Device name
Instrument, Measuring, Corneal Radius
Regulation
21 CFR 886.1450
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
5
Ingested recalls
2

Clearances, product code HJB

By decision year
5 clearances under product code HJB with a decision year between 1985 and 1993, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HJB by decision year
YearClearances
19851
19862
19932

Applicants with the most clearances

Product code HJB
Applicants holding the most 510(k) clearances under product code HJB
ApplicantClearances
Acufex Microsurgical, Inc.1
Heidelberg Instruments1
Kera Corp.1
Marco Ophthalmic, Inc.1
R.H. Burton Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order