Panels › General Hospital › Product code FRL · Class 1
Fiber, Medical, Absorbent
Regulation 880.5300
0510(k)s in 12 months (19 all time)
0recalls in 12 months (6 all time)
1recalls that name a 510(k)
Top companies in FRL
| Company | 510(k)s | Recalls |
|---|---|---|
| American Hospital Supply Corp. | 4 | 0 |
| American Surgical Company | 0 | 2 |
| Medical Engineering Corp. | 2 | 0 |
| 3M Company / Medical Division | 0 | 1 |
| Associated Medical Products Co. | 1 | 0 |
| Carapace, Inc. | 1 | 0 |
| Coloplast Corp Skin Care Div | 0 | 1 |
| Dexide, Inc. | 1 | 0 |
| Icn Pharmaceuticals, Inc. | 1 | 0 |
| Jelco Laboratories | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2021 | Medline Industries Inc Cotton Rounds/Pads under the following brand names:
1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft and strong 100 count;
2. BEAUTY 360 Premium Cotton Rounds - two textures soft an Terminated |
FRL | None listed |
| Dec 11, 2017 | Medical Action Industries Inc Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile
This OR towel product is intended for external use only. These towels are intended to Terminated |
FRL | None listed |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Non-Strung 1/8"
Ref Number: 31-07
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
FRL | K854714 |
| Mar 31, 2016 | American Surgical Company American Surgical Cotton Balls-Non-Strung 1"
Ref Number: 31-04
Product Usage:
Neurosurgical and Nonneurosurgical Sponges Terminated |
FRL | None listed |
| Sep 4, 2009 | Coloplast Corp Skin Care Div Coloplast, InterDry Ag 10" x 144" Roll P/N 6791001400, Manufactured for Coloplast A/S DK-3050 Humlebaek, Denmark, Distributed by Coloplast Corp Minneapolis MN 55411.
InterDry" is a non-sterile, kni Terminated |
FRL | None listed |
| Jul 13, 2006 | 3M Company / Medical Division 3M Nexcare First Aid High Performance Gauze Pad. Individually wrapped & sterile. catalog # 434-10. 3M Consumer Health Care, St. Paul, MN 55144-1000. Made in USA. UPC 05113166774. Terminated |
FRL | None listed |
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