12 results
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78ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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.
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 25, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
FDA Enforcement
Class II
·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
FDA Enforcement
Class I
·Terminated·Deroyal Industries, Inc. Lafollette·October 6, 2021