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

Bandage, Elastic

21 CFR 880.5075 / General Hospital
FDA source (opens on fda.gov)

FQM is the FDA product code for Bandage, Elastic, a class I device type, regulated under 21 CFR 880.5075. As of , FDA records hold 42 510(k) clearances under this code, the most recent dated , and 30 recalls.

Classification record

Product code
FQM
Device name
Bandage, Elastic
Regulation
21 CFR 880.5075
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
42
Ingested recalls
30

Clearances, product code FQM

By decision year
42 clearances under product code FQM with a decision year between 1976 and 2004, 1980 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code FQM by decision year
YearClearances
19765
19773
19784
19795
198011
19812
19823
19832
19842
19871
19951
20011
20042

Applicants with the most clearances

Product code FQM
Applicants holding the most 510(k) clearances under product code FQM
ApplicantClearances
Conco Medical Co.5
Abco Dealers, Inc.3
Stan-Pak Ent.3
Beiersdorf, Inc.2
Conphar, Inc.2
Pollak (Intl.).ltd2
Secol Co.2
The Owenby Co.2
Alba-Waldensian, Inc.1
Anago, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 669 companies shown, in name order