510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
MXCClass II

Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

21 CFR 870.2800 / Cardiovascular
FDA source (opens on fda.gov)

MXC is the FDA product code for Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection), a class II device type, regulated under 21 CFR 870.2800. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
MXC
Device name
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Regulation
21 CFR 870.2800
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
23
Ingested recalls
5

Clearances, product code MXC

By decision year
23 clearances under product code MXC with a decision year between 1998 and 2023, 2019 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MXC by decision year
YearClearances
19981
20001
20012
20072
20081
20092
20101
20122
20141
20172
20193
20203
20211
20231

Applicants with the most clearances

Product code MXC
Applicants holding the most 510(k) clearances under product code MXC
ApplicantClearances
Abbott Medical9
Abbott (St. Jude Medical)5
Medtronic, Inc.4
Transoma Medical2
St. Jude Medical, Cardiac Rhythm Management Divisi1
Transnoma Medical, Inc.1
Transoma1

Companies listing this code with FDA

Companies whose registered establishments list this code