BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    SURE-FLEX ANASTOMOTIC BALLOON DILATOR

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

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083010799·Fixed, 4 electrode, RVB, 10mm electrode spacing

    TRU® NP Cover Screw .050" Hex, 3.5 mm, Ti

    FDA UDI
    STERNGOLD DENTAL LLC·00841549107818·The TRU is a self-tapping, double thread screw ...

    CNS-9300 SERIES CENTRAL STATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    UNK

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code KNS·June 13, 2014

    FOLFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 30, 2014

    FORERUNNER AED, US ENGLISH, REFURB

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICLA SYSTEMS·Product code MKJ·January 2, 2013

    C-FLEX

    FDA Adverse Event
    Injury ·RAYNER INTRAOCULAR LENSES LTD.·Product code HQL·November 11, 2010

    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

    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