BEUDAMED
    86 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

    FDA Enforcement
    Class II ·Ongoing·MAX LUX CORP·December 8, 2021

    AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

    FDA Enforcement
    Class II ·Ongoing·Aesculap AG·October 8, 2025

    AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

    FDA Enforcement
    Class II ·Ongoing·Aesculap AG·October 8, 2025

    The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 9, 2020

    S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD o P40554 - ASM, MFR HANDLE REPAIR, FIXED, S-SERIES, STANDARD o P46269 - ASSY, MFR CONTROLLER UPGRADE, STANDARD

    FDA Enforcement
    Class II ·Ongoing·Stryker Communications·March 31, 2021

    MEDICAL CHEMICAL CORPORATION Total-Fix STOOL COLL KIT, TOTAL FIX PARASITOLOGY (100/CS) Catalog # NC0585129

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022

    LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert

    FDA Enforcement
    Class II ·Ongoing·CORENTEC CO., LTD·June 12, 2024

    Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No

    FDA Enforcement
    Class II ·Ongoing·SEASPINE ORTHOPEDICS CORPORATION·July 24, 2024

    PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.

    FDA Enforcement
    Class II ·Ongoing·B BRAUN MEDICAL INC·October 15, 2025

    Azurion IGTS Fixed Systems

    FDA Enforcement
    Class II ·Ongoing·Philips North America·November 15, 2023

    Allura Xper IGTS Fixed Systems

    FDA Enforcement
    Class II ·Ongoing·Philips North America·November 15, 2023

    Integris-Allura IGTS Fixed Systems

    FDA Enforcement
    Class II ·Ongoing·Philips North America·November 15, 2023

    IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·August 14, 2024

    IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·August 14, 2024

    IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·August 14, 2024

    IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·August 14, 2024

    ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.

    FDA Enforcement
    Class II ·Ongoing·DePuy Orthopaedics, Inc.·April 10, 2024

    ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020