BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    Ignite Anatomic Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNIVENT TUBE (TCB TYPE)

    FDA UDI
    FUJI SYSTEMS CORPORATION·04544050055154·ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is i...

    UNIVENT TUBE (TCB TYPE)

    FDA UDI
    FUJI SYSTEMS CORPORATION·04544050123808·ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is i...

    NA

    FDA UDI
    Synthes GmbH·10886982144492·3.0MM CANNULATED SCREW LONG THREAD/16MM

    Vu a-POD™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981037925·27x21mm Trial 16mm 8 deg. The Vu a-POD interver...

    Diamond Orthopedic, LLC

    FDA UDI
    DIAMOND ORTHOPEDIC, LLC·B551DMD2027160·3.0mm, Cannulated Screw, Long Thd., 16mm

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF2027160·3.0mm Cannulated Screw, Long Thread, 16mm

    MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS

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

    CONNECTA Q-SYTE WHT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·October 15, 2025

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 22, 2014

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code DHA·August 11, 2011

    ENDOPATH** ETS FLEX45

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 2, 2013

    SMARTPHONE ANDROID APP: PUMP CONNECT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code PKU·August 11, 2025

    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