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

Monitor, St Segment With Alarm

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

MLD is the FDA product code for Monitor, St Segment With Alarm, a class II device type, regulated under 21 CFR 870.1025. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
MLD
Device name
Monitor, St Segment With Alarm
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
14
Ingested recalls
2

Clearances, product code MLD

By decision year
14 clearances under product code MLD with a decision year between 1993 and 2010, 1996 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MLD by decision year
YearClearances
19931
19951
19962
19972
19982
19991
20001
20011
20021
20081
20101

Applicants with the most clearances

Product code MLD
Applicants holding the most 510(k) clearances under product code MLD
ApplicantClearances
GE Healthcare3
Hewlett-Packard Co.2
Siemens Medical Solutions USA, Inc.2
Criticare Systems, Inc.1
Datex Division Instrumentarium Corp.1
Invivo Research, Inc.1
Marquette Electronics, Inc.1
Medical Data Electronics1
Philips North America LLC1
Protocol Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 42 companies shown, in name order