510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
HMYClass I

Keratome, Battery-Powered

21 CFR 886.4370 / Ophthalmic
FDA source (opens on fda.gov)

HMY is the FDA product code for Keratome, Battery-Powered, a class I device type, regulated under 21 CFR 886.4370. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
HMY
Device name
Keratome, Battery-Powered
Regulation
21 CFR 886.4370
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
12
Ingested recalls
2

Clearances, product code HMY

By decision year
12 clearances under product code HMY with a decision year between 1978 and 2004, 2002 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HMY by decision year
YearClearances
19781
19901
19982
19992
20001
20011
20023
20041

Applicants with the most clearances

Product code HMY
Applicants holding the most 510(k) clearances under product code HMY
ApplicantClearances
Moria SA5
Becton Dickinson & Co2
Insight Technologies Instruments, LLC2
Cerenovus, Inc.1
Industrial & Medical Design, Inc.1
Visitec Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code