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

Cannula, Ophthalmic

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

HMX is the FDA product code for Cannula, Ophthalmic, a class I device type, regulated under 21 CFR 886.4350. As of , FDA records hold 77 510(k) clearances under this code, the most recent dated , and 28 recalls.

Classification record

Product code
HMX
Device name
Cannula, 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
77
Ingested recalls
28

Clearances, product code HMX

By decision year
77 clearances under product code HMX with a decision year between 1977 and 2001, 1988 the highest year at 33.
Show the numbers
510(k) clearances under FDA product code HMX by decision year
YearClearances
19771
19794
19801
19812
19822
19832
19842
19854
19863
198711
198833
19891
19901
19911
19922
19943
19951
19971
20001
20011

Applicants with the most clearances

Product code HMX
Applicants holding the most 510(k) clearances under product code HMX
ApplicantClearances
Advanced Surgical Products, Inc.29
MicroSurgical Technology Inc6
Look, Inc.5
Visitec Co.3
Myocure, Inc.2
Storz Instrument Co.2
Van Dellen, Ltd.2
American Medical Devices, Inc.1
American V. Mueller1
Biomedical Dynamics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 208 companies shown, in name order