BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    PACSPLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Safco Surgical Length Bur

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310234603·Safco surgical length bur, #556 crosscut straig...

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120234601·Carbide, round, rosehead, fast cutting, green ring

    SWIFT LOW PROFILE CUP (PRO CUP)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BENDING IRON FOR 2.7MM & 3.5MMPLATES

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code LXH·March 27, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 18, 2011

    CLEARSTAR PUMP

    FDA Adverse Event
    Malfunction ·ROSS PRODUCTS DIVISION·Product code LZH·April 2, 2008

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHA·January 7, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018