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

Punch, Biopsy, Surgical

21 CFR 872.4565 / Dental
FDA source (opens on fda.gov)

EME is the FDA product code for Punch, Biopsy, Surgical, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
EME
Device name
Punch, Biopsy, Surgical
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
1

Clearances, product code EME

By decision year
3 clearances under product code EME with a decision year between 1989 and 1994, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EME by decision year
YearClearances
19891
19911
19941

Applicants with the most clearances

Product code EME
Applicants holding the most 510(k) clearances under product code EME
ApplicantClearances
Buckman Co., Inc.1
Byron Medical1
Pulpdent Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 85 companies shown, in name order