ClearanceBrief
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

CodeDeviceRecords
LROGeneral Surgery Tray11
LRPTray, Surgical4
HFXClamp, Circumcision2
KGXTape And Bandage, Adhesive2
DWSInstruments, Surgical, Cardiovascular1
KDDKit, Surgical Instrument, Disposable1
OFDCatheter Introducer Kit1
OGDCustom Anesthesia Tray1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 29, 2021Deroyal Industries, Inc. Lafollette
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Terminated
LROK842648
Feb 19, 2020Deroyal 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
DWSNone listed
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17
Terminated
LROK842648
Feb 19, 2020Deroyal Industries, Inc. Lafollette
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
Terminated
LROK842648
Apr 17, 2012Deroyal 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
KGXNone listed
Apr 17, 2012Deroyal 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
KDDNone listed
Apr 17, 2012Deroyal 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
KGXNone listed
Oct 6, 2011Deroyal 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
OFDNone listed
Oct 6, 2011Deroyal 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
OGDNone listed
Sep 16, 2011Deroyal 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
HFXNone listed
Sep 16, 2011Deroyal 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
HFXNone listed
Jul 28, 2011Deroyal 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
LRPNone listed
May 20, 2011Deroyal 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
LRPNone listed
May 20, 2011Deroyal 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
LRPNone listed
May 20, 2011Deroyal 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
LRPNone listed
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