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

Transilluminator, Ac-Powered

21 CFR 886.1945 / Ophthalmic
FDA source (opens on fda.gov)

HJM is the FDA product code for Transilluminator, Ac-Powered, a class II device type, regulated under 21 CFR 886.1945. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
HJM
Device name
Transilluminator, Ac-Powered
Regulation
21 CFR 886.1945
Device class
Class II
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
12
Ingested recalls
3

Clearances, product code HJM

By decision year
12 clearances under product code HJM with a decision year between 1981 and 1997, 1994 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HJM by decision year
YearClearances
19812
19892
19911
19944
19952
19971

Applicants with the most clearances

Product code HJM
Applicants holding the most 510(k) clearances under product code HJM
ApplicantClearances
Peregrine Surgical, LLC.2
Radiation Measurements, Inc.2
Hgm, Inc.1
Infinitech, Inc.1
Intl. Ophthalmic Industries Corp.1
Keeler Instruments, Inc.1
Storz Instrument Co.1
Vision Medical Inc1
Visitec Co.1
Wells Johnson Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code