Company
Deroyal Industries, Inc. Lafollette
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
23recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2021 | Deroyal Industries, Inc. Lafollette DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures. Terminated |
DWS | None listed |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
ASC Ocular Plastics Pack 89-6498.13 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Kwik Kit 89-6389.06 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Ophthalmology CSTM PCK 89-6387.08 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
ASC Thyroid Pack 89-6302.14 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
ASC Laparoscopy Pack 89-6138.13 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Cystoscopy Pack 89-6071.15 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
ASC General Pack 89-6015.16 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Shoulder Pack 89-4751.08 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Chronic Ear Pack 89-4393.17 Terminated |
LRO | K842648 |
| Feb 19, 2020 | Deroyal Industries, Inc. Lafollette DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following:
Outpatient Major 89-3865.12; Terminated |
LRO | K842648 |
| Apr 17, 2012 | Deroyal Industries, Inc. Lafollette Non-sterile wound closure strips, packaged as follows:
DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-202N, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoya Terminated |
KGX | None listed |
| Apr 17, 2012 | Deroyal Industries, Inc. Lafollette Sterile sterile surgical kits containing Episeal products, packaged as follows:
DeRoyal CLINIC PICC KIT, REF 47-483, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell T Terminated |
KDD | None listed |
| Apr 17, 2012 | Deroyal Industries, Inc. Lafollette Sterile wound closure strips, packaged as follows:
DeRoyal EPISEAL, Wound Closure Strips, REF 46-202, STERILE R, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeR Terminated |
KGX | None listed |
| Oct 6, 2011 | Deroyal Industries, Inc. Lafollette DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA:
Intended Use: Varies by kit; an anesthesia bre Terminated |
OFD | None listed |
| Oct 6, 2011 | Deroyal Industries, Inc. Lafollette Custom anesthesia kits labeled as follows:
(1) DeRoyal (R) Adult Exp Anesthesia Circuit, REF 86-001737, Rx Only, NON-STERILE, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN Terminated |
OGD | None listed |
| Sep 16, 2011 | Deroyal Industries, Inc. Lafollette Circumcision trays and packs listed as follows:
(1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, Terminated |
HFX | None listed |
| Sep 16, 2011 | Deroyal Industries, Inc. Lafollette DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA
Circumcision Clamp Terminated |
HFX | None listed |
| Jul 28, 2011 | Deroyal Industries, Inc. Lafollette DeRoyal (R) Incision and Drainage Tray, RES 47-763.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA
Lot Numbers: 20641391, 21092240, 21950988, Terminated |
LRP | None listed |
| May 20, 2011 | Deroyal Industries, Inc. Lafollette Kits and Trays containing lubricant:
GEO-MED BASIC CYSTO PACK, V A CENTRAL PLAINS HEALTH NET, REF 50-13272.05, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Terminated |
LRP | None listed |
| May 20, 2011 | Deroyal Industries, Inc. Lafollette Kits and Trays containing alcohol swabstick/prep pad:
GEO-MED BIOPSY TRAY, V A MED CTR MARTINSBURG, REF 89-7617.01
Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB Terminated |
LRP | None listed |
| May 20, 2011 | Deroyal Industries, Inc. Lafollette Kits and Trays containing both alcohol swabstick/prep pad and lubricant: DeRoyal (R) AMNIOCENTESIS TRAY, LINK DREW LACO HOSP, REF 50-11656.02, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries Terminated |
LRP | None listed |