Home › Device types › FRL
Fiber, Medical, Absorbent
FDA product code FRL · Class 1 · General Hospital
1,105
Registered devices
197
Adverse events
6
Recalls
19
510(k) clearances
Devices with this code
Britedent — Bright Supply, Inc.Curity — Cardinal Health 200, LLCBioseal Inc. — BIOSEALBioseal Inc. — BIOSEALHenry Schein — HENRY SCHEIN, INC.Curity — Cardinal Health 200, LLCCurity — Cardinal Health, Inc.Airo™ CPAP Mask Liners — Athfar 828 IncMEDSAF 10 x 12.5cm — MANUKAMED LIMITED PARTNERSHIPTOWEL PERVAL — STANDARD TEXTILE CO., INC.Dermacea — Cardinal Health, Inc.SOFSORB OR TOWEL — STANDARD TEXTILE CO., INC.Fischerbrand — U.S. COTTON, LLCKOSMA-KARE — Kosma-Kare Canada IncTOWEL PERVAL — STANDARD TEXTILE CO., INC.AllCare, INC — ALLCARE, INCDeRoyal — DEROYAL INDUSTRIES, INC.NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLCNOVO Health Services, LLC — NOVO HEALTH SERVICES, LLCAvaline Medical NJ LLC — Avaline Medical NJ Limited Liability CompanyA Plus — A PLUS INTERNATIONAL INC.DeRoyal — DEROYAL INDUSTRIES, INC.80531 Blue Absorbent Mat - Super; Non-slip; 500g; 32"x40" — XODUS MEDICAL, INC.AllCare, INC — ALLCARE, INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-05-25 | Medline Industries Inc | Potential for mold contamination (Aspergillus vadensis) |
| 2017-12-11 | Medical Action Industries Inc | Product sterility potentially compromised. |
| 2016-03-31 | American Surgical Company | Product packaging defective compromising sterility |
| 2016-03-31 | American Surgical Company | Product packaging defective compromising sterility |
| 2009-07-21 | Coloplast Corp Skin Care Div | Coloplast determined that a portion of one lot of InterDry" Ag Lot number 1789435, did not meet the product specification for silver content. In this portion o |
| 2006-02-09 | 3M Company / Medical Division | After reviewing manufacturing records it has been determined that these lots inadvertently were not sterilized after packaging in individual boxes labeled as st |
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