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

Marker, Radiographic, Implantable

21 CFR 878.4300 / General, Plastic Surgery
FDA source (opens on fda.gov)

NEU is the FDA product code for Marker, Radiographic, Implantable, a class II device type, regulated under 21 CFR 878.4300. As of , FDA records hold 110 510(k) clearances under this code, the most recent dated , and 14 recalls.

Classification record

Product code
NEU
Device name
Marker, Radiographic, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
110
Ingested recalls
14

Clearances, product code NEU

By decision year
110 clearances under product code NEU with a decision year between 2001 and 2026, 2024 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code NEU by decision year
YearClearances
20014
20023
20032
20045
20052
20064
20074
20087
20094
20105
20113
20123
20137
20143
20157
20162
20174
20188
20195
20203
20213
20222
20234
202410
20255
20261

Applicants with the most clearances

Product code NEU
Applicants holding the most 510(k) clearances under product code NEU
ApplicantClearances
Devicor Medical Products Inc9
Senorx, Inc.7
Biopsy Sciences, LLC6
Carbon Medical Technologies, Inc.6
SOMATEX Medical Technologies GmbH6
Molli Surgical, Inc.5
Focal Therapeutics4
Inrad4
Scion Medical Technologies, LLC4
Bard Peripheral Vascular Inc3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 86 companies shown, in name order