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

Incubator, Neonatal

21 CFR 880.5400 / General Hospital
FDA source (opens on fda.gov)

FMZ is the FDA product code for Incubator, Neonatal, a class II device type, regulated under 21 CFR 880.5400. As of , FDA records hold 86 510(k) clearances under this code, the most recent dated , and 43 recalls.

Classification record

Product code
FMZ
Device name
Incubator, Neonatal
Regulation
21 CFR 880.5400
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
86
Ingested recalls
43

Clearances, product code FMZ

By decision year
86 clearances under product code FMZ with a decision year between 1978 and 2026, 1991 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code FMZ by decision year
YearClearances
19782
19804
19812
19824
19831
19841
19873
19882
19893
19904
19918
19923
19935
19942
19962
19971
19982
19991
20004
20011
20023
20031
20042
20063
20073
20081
20104
20111
20141
20151
20161
20171
20182
20192
20221
20252
20262

Applicants with the most clearances

Product code FMZ
Applicants holding the most 510(k) clearances under product code FMZ
ApplicantClearances
GE Healthcare21
Air-Shields, Inc.7
Air-Shields Vickers, Inc.6
Atom Medical Corporation5
Vickers America Medical Corp.4
Dragerwerk AG2
Drägerwerk AG & Co. KGaA2
Hill-Rom Air-Shields2
Hollister, Inc.2
K-1 Medical Products, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order