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

Syringe, Piston

21 CFR 880.5860 / General Hospital
FDA source (opens on fda.gov)

FMF is the FDA product code for Syringe, Piston, a class II device type, regulated under 21 CFR 880.5860. As of , FDA records hold 752 510(k) clearances under this code, the most recent dated , and 305 recalls.

Classification record

Product code
FMF
Device name
Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
752
Ingested recalls
305

Clearances, product code FMF

By decision year
752 clearances under product code FMF with a decision year between 1976 and 2026, 1988 the highest year at 35.
Show the numbers
510(k) clearances under FDA product code FMF by decision year
YearClearances
19763
197711
19788
19793
19803
198115
198229
198312
198424
198524
198615
198721
198835
198921
199017
199110
199215
199314
199419
199527
199615
19979
199816
199910
200018
200111
200215
200310
200414
200516
200617
200723
20089
200914
201011
201115
20129
201312
201412
20159
201612
201713
20188
201911
202015
202120
202224
202322
202414
202513
20269

Applicants with the most clearances

Product code FMF
Applicants holding the most 510(k) clearances under product code FMF
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic23
Sherwood Medical Co.20
Becton Dickinson & Co19
Merit Medical Systems, Inc.10
Terumo Medical Corp.10
Nipro Medical Corporation9
Abco Dealers, Inc.7
Abbott Medical7
Mac Lee Medical Products7
Promisemed Hangzhou Meditech Co.,Ltd.7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 475 companies shown, in name order