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

Monitor, Uterine Contraction, External (For Use In Clinic)

21 CFR 884.2720 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HFM is the FDA product code for Monitor, Uterine Contraction, External (For Use In Clinic), a class II device type, regulated under 21 CFR 884.2720. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
HFM
Device name
Monitor, Uterine Contraction, External (For Use In Clinic)
Regulation
21 CFR 884.2720
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
23
Ingested recalls
8

Clearances, product code HFM

By decision year
23 clearances under product code HFM with a decision year between 1984 and 2014, 1989 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HFM by decision year
YearClearances
19842
19862
19882
19893
19903
19912
19931
19951
19961
20002
20021
20041
20061
20141

Applicants with the most clearances

Product code HFM
Applicants holding the most 510(k) clearances under product code HFM
ApplicantClearances
Aequitron Medical, Inc.2
Corometrics Medical Systems, Inc.2
Tokos Medical Corp.2
Ventrex, Inc.2
Advantage Medical Systems, Inc.1
Air-Shields Vickers, Inc.1
American I.V. Products, Inc.1
Carelink1
Clinical Innovations, LLC1
Epic Medical Equipment Services, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code