BEUDAMED
    21 results · 27ms · Sources: EU EUDAMED, US FDA

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    ACROSEAL ROOT CANAL OR APICAL SEALER

    FDA 510(k)
    FDA Class 2 ·Dental

    Safco D1amond

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·10810063751668·Sterile Single Use Burs - ISO Code 856L-016XC

    BOEHRINGER MRI SUCTION REGULATORY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BAUMER MULLER HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MULTI-DRUG ONE STEP SCREEN TEST PANEL (URINE)

    FDA Adverse Event
    Malfunction ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code LFG·April 1, 2024

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·March 27, 2013

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·March 10, 2011

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·April 4, 2008

    ENDOPATH XCEL TROCAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·February 17, 2022

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·February 16, 2022

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021