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

Forceps, Rongeur, Surgical

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

EMH is the FDA product code for Forceps, Rongeur, Surgical, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EMH
Device name
Forceps, Rongeur, 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
8
Ingested recalls
0

Clearances, product code EMH

By decision year
8 clearances under product code EMH with a decision year between 1977 and 1989, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EMH by decision year
YearClearances
19771
19821
19842
19851
19861
19892

Applicants with the most clearances

Product code EMH
Applicants holding the most 510(k) clearances under product code EMH
ApplicantClearances
Kinetic Medical Products2
Artiberia1
C.B.S. Biotechnics, Inc.1
Downs Surgical, Ltd.1
Imm Enterprises, Ltd.1
Premier Dental Products Co1
Biomet Microfixation1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 162 companies shown, in name order