11 results · 25ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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