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

System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)

21 CFR 884.2982 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

KXZ is the FDA product code for System, Thermographic, Liquid Crystal, Powered (Adjunctive Use), a class III device type, regulated under 21 CFR 884.2982. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KXZ
Device name
System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
Regulation
21 CFR 884.2982
Device class
Class III
Review panel
Obstetrics/Gynecology
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code KXZ

By decision year
7 clearances under product code KXZ with a decision year between 1977 and 1985, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KXZ by decision year
YearClearances
19772
19791
19821
19842
19851

Applicants with the most clearances

Product code KXZ
Applicants holding the most 510(k) clearances under product code KXZ
ApplicantClearances
E-Z-EM, Inc2
American Thermal Instruments, LLC1
Bcd Products, Inc.1
Cutter Laboratories, Inc.1
MedTech Products, Inc.1
Qmax Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code KXZ.