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

Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

21 CFR 878.4700 / General, Plastic Surgery
FDA source (opens on fda.gov)

HRM is the FDA product code for Microscope, Operating & Accessories, Ac-Powered, Ophthalmic, a class I device type, regulated under 21 CFR 878.4700. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
HRM
Device name
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Regulation
21 CFR 878.4700
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
14
Ingested recalls
7

Clearances, product code HRM

By decision year
14 clearances under product code HRM with a decision year between 1979 and 1993, 1985 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code HRM by decision year
YearClearances
19791
19821
19841
19855
19892
19922
19932

Applicants with the most clearances

Product code HRM
Applicants holding the most 510(k) clearances under product code HRM
ApplicantClearances
Keeler Instruments, Inc.4
Alcon Laboratories1
Carl Zeiss, Inc.1
Hill-Med, Inc.1
Lumenis Ltd1
Marco Ophthalmic, Inc.1
Mentor O & O, Inc.1
Prescott's, Inc.1
Seltrex, Corp.1
Treace Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 57 companies shown, in name order