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

Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)

21 CFR 870.1025 / Cardiovascular
FDA source (opens on fda.gov)

MXD is the FDA product code for Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection), a class II device type, regulated under 21 CFR 870.1025. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
MXD
Device name
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
34
Ingested recalls
10

Clearances, product code MXD

By decision year
34 clearances under product code MXD with a decision year between 2014 and 2026, 2023 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code MXD by decision year
YearClearances
20142
20152
20163
20174
20191
20204
20214
20222
20236
20241
20253
20262

Applicants with the most clearances

Product code MXD
Applicants holding the most 510(k) clearances under product code MXD
ApplicantClearances
Medtronic, Inc.16
BIOTRONIK AG11
Boston Scientific Corporation4
Abbott Medical2
Medtronic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code