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

Imager, Ultrasonic Obstetric-Gynecologic

21 CFR 884.2225 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HEM is the FDA product code for Imager, Ultrasonic Obstetric-Gynecologic, a class II device type, regulated under 21 CFR 884.2225. As of , FDA records hold 30 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HEM
Device name
Imager, Ultrasonic Obstetric-Gynecologic
Regulation
21 CFR 884.2225
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
30
Ingested recalls
1

Clearances, product code HEM

By decision year
30 clearances under product code HEM with a decision year between 1976 and 1995, 1985 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HEM by decision year
YearClearances
19762
19772
19781
19812
19832
19842
19854
19864
19882
19893
19902
19912
19952

Applicants with the most clearances

Product code HEM
Applicants holding the most 510(k) clearances under product code HEM
ApplicantClearances
General Electric Co.4
Advanced Technology Laboratories, Inc.2
Corometrics Medical Systems, Inc.2
GE Medical Systems Information Technologies, Inc.2
Air-Shields, Inc.1
Ausonics Pty, Ltd.1
Digisonics, Inc1
Elscint, Inc.1
Fukuda Denshi USA, Inc.1
International Biomedics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code