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

Transducer, Tremor

21 CFR 882.1950 / Neurology
FDA source (opens on fda.gov)

GYD is the FDA product code for Transducer, Tremor, a class II device type, regulated under 21 CFR 882.1950. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GYD
Device name
Transducer, Tremor
Regulation
21 CFR 882.1950
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
15
Ingested recalls
0

Clearances, product code GYD

By decision year
15 clearances under product code GYD with a decision year between 1979 and 2026, 2022 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GYD by decision year
YearClearances
19791
19971
20012
20071
20141
20161
20223
20231
20251
20263

Applicants with the most clearances

Product code GYD
Applicants holding the most 510(k) clearances under product code GYD
ApplicantClearances
GKC Manufacturing Pty Ltd3
Axon Instruments, Inc.1
Cleveland Medical Devices, Inc.1
Columbus Instruments Intl. Corp.1
EMPATICA S.r.l.1
Flexable Systems, Inc.1
H2o Bilisim Yazilim1
Kneu Health Digital , Ltd.1
Neuhealth Digital, Ltd.1
New Touch Digital, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code