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

Bed, Pediatric Open Hospital

21 CFR 880.5140 / General Hospital
FDA source (opens on fda.gov)

FMS is the FDA product code for Bed, Pediatric Open Hospital, a class II device type, regulated under 21 CFR 880.5140. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
FMS
Device name
Bed, Pediatric Open Hospital
Regulation
21 CFR 880.5140
Device class
Class II
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
27
Ingested recalls
5

Clearances, product code FMS

By decision year
27 clearances under product code FMS with a decision year between 1981 and 1997, 1986 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code FMS by decision year
YearClearances
19811
19821
19853
19865
19883
19901
19911
19921
19933
19954
19963
19971

Applicants with the most clearances

Product code FMS
Applicants holding the most 510(k) clearances under product code FMS
ApplicantClearances
Infant Advantage, Inc.5
International Purchasing Services3
Pedicraft, Inc.3
Janco Consulting Services2
Cambridge Scientific1
Cinventa AB1
Daun International, Inc.1
Hospital Supply Co., Inc.1
Midmark Corp1
N.K. Medical Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order