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

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    GAMBRO QUICKSET BLOODLINES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111209598·RABINER NEURO HAMMER

    MODIFIED 650 MAMMOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    STERRAD 50 & STERRAD 100S STERILIZERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PERFORMA DIAGNOSTIC CATHETERS

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·April 11, 2013

    PUMP MMT-712LNAS PRDGM INS SK EN US LN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·June 19, 2008

    COATED VICRYL SUTURE

    FDA Adverse Event
    Injury ·ETHICON INC·Product code GAM·April 19, 2011

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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