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

Dressing, Wound, Drug

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FDA source (opens on fda.gov)

FRO is the FDA product code for Dressing, Wound, Drug. As of , FDA records hold 707 510(k) clearances under this code, the most recent dated , and 82 recalls.

Classification record

Product code
FRO
Device name
Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
709
Ingested recalls
82

Clearances, product code FRO

By decision year
709 clearances under product code FRO with a decision year between 1978 and 2026, 2009 the highest year at 31.
Show the numbers
510(k) clearances under FDA product code FRO by decision year
YearClearances
19781
19791
19803
19812
198210
198312
198411
198512
198613
198716
198813
198923
19906
19916
19927
19937
199412
199515
19962
199712
19987
199915
20006
20017
20026
200310
200415
200515
200621
200729
200826
200931
201031
201127
201224
201319
201422
201528
201628
201723
201820
201916
202012
20218
20229
202318
202424
202511
202617

Applicants with the most clearances

Product code FRO
Applicants holding the most 510(k) clearances under product code FRO
ApplicantClearances
Sonoma Pharmaceuticals, Inc.22
MEDLINE INDUSTRIES, LP - Northfield21
Advanced Medical Solutions Limited19
Convatec, A Division of E.R. Squibb & Sons16
HuiZhou Foryou Medical Devices Co., Ltd.16
Derma Sciences, Inc.12
Winner Medical Co., Ltd.12
Acrymed, Inc.9
Argentum Medical, LLC9
Puricore, Inc.8

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 331 companies shown, in name order