BEUDAMED
    197 results · 23ms · 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.
    Filters FDA Enforcement × Status: Terminated × Clear all

    Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·May 29, 2013

    Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.

    FDA Enforcement
    Class III ·Terminated·Stanbio Laboratory, LP·August 11, 2021

    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 Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.

    FDA Enforcement
    Class III ·Terminated·Stanbio Laboratory, LP·August 11, 2021

    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