177 results · 20ms · 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.

Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905

FDA Enforcement
Class II ·Terminated·Thermo Fisher Scientific (Monterrey)·November 13, 2019

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: 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: Kwik Kit 89-6389.06

FDA Enforcement
Class II ·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020

Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904

FDA Enforcement
Class II ·Terminated·Thermo Fisher Scientific (Monterrey)·November 13, 2019

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: 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 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: 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: 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: 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: ASC Ocular Plastics Pack 89-6498.13

FDA Enforcement
Class II ·Terminated·Deroyal Industries, Inc. Lafollette·March 11, 2020

Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.

FDA Enforcement
Class II ·Terminated·Cardinal Health 200, LLC·July 15, 2020

Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.

FDA Enforcement
Class II ·Terminated·Cardinal Health 200, LLC·July 15, 2020

Cardinal Health Tiny Toes; 11470-010T Infant heel warmer

FDA Enforcement
Class II ·Terminated·Philips Electronics North America Corporation·December 30, 2015

Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

FDA Enforcement
Class II ·Terminated·Degania Silicone, Ltd.·August 21, 2019

Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

FDA Enforcement
Class II ·Terminated·Degania Silicone, Ltd.·August 21, 2019

Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

FDA Enforcement
Class II ·Terminated·Degania Silicone, Ltd.·August 21, 2019

Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

FDA Enforcement
Class II ·Terminated·Degania Silicone, Ltd.·August 21, 2019

Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

FDA Enforcement
Class II ·Terminated·Degania Silicone, Ltd.·August 21, 2019