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

Headrest, Neurosurgical

21 CFR 882.4440 / Neurology
FDA source (opens on fda.gov)

HBM is the FDA product code for Headrest, Neurosurgical, a class I device type, regulated under 21 CFR 882.4440. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
HBM
Device name
Headrest, Neurosurgical
Regulation
21 CFR 882.4440
Device class
Class I
Review panel
Neurology
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
2

Clearances, product code HBM

By decision year
3 clearances under product code HBM with a decision year between 1982 and 1991, 1991 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HBM by decision year
YearClearances
19821
19912

Applicants with the most clearances

Product code HBM
Applicants holding the most 510(k) clearances under product code HBM
ApplicantClearances
Cerenovus, Inc.2
Kelleher Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order