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

Needle, Aspiration And Injection, Reusable

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

GDM is the FDA product code for Needle, Aspiration And Injection, Reusable, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 48 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
GDM
Device name
Needle, Aspiration And Injection, Reusable
Regulation
21 CFR 878.4800
Device class
Class I
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
48
Ingested recalls
4

Clearances, product code GDM

By decision year
48 clearances under product code GDM with a decision year between 1977 and 2007, 1988 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code GDM by decision year
YearClearances
19771
19781
19791
19801
19821
19831
19844
19851
19864
19873
19889
19896
19907
19922
19931
19941
19952
19971
20071

Applicants with the most clearances

Product code GDM
Applicants holding the most 510(k) clearances under product code GDM
ApplicantClearances
Downs Surgical, Ltd.5
Popper & Sons, Inc.3
Bioaccess, Inc.2
E.G. Dick & Assoc.2
E.L. Medico Intl., Inc.2
Go Medical Industries Pty., Ltd.2
Radiation Development Co., Inc.2
A & A Medical, Inc.1
A.D.T. Lab Industries1
American Design Group, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 102 companies shown, in name order