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

Drape, Patient, Ophthalmic

21 CFR 878.4370 / General, Plastic Surgery
FDA source (opens on fda.gov)

HMT is the FDA product code for Drape, Patient, Ophthalmic, a class II device type, regulated under 21 CFR 878.4370. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HMT
Device name
Drape, Patient, Ophthalmic
Regulation
21 CFR 878.4370
Device class
Class II
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
7
Ingested recalls
1

Clearances, product code HMT

By decision year
7 clearances under product code HMT with a decision year between 1983 and 1995, 1983 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HMT by decision year
YearClearances
19832
19861
19872
19911
19951

Applicants with the most clearances

Product code HMT
Applicants holding the most 510(k) clearances under product code HMT
ApplicantClearances
Angiosystems, Inc.1
Charles Atkins & Co.1
CooperVision, Inc.1
Solos Ophthalmology1
Sur-Tech, Inc.1
Treace Medical, Inc.1
Visitec Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 38 companies shown, in name order