BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AF811

    FDA UDI
    Respironics, Inc.·00606959007659·AF811 Mask, with Headgear, Single Use, Large

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193104522·HA PEEK EVOS Curved, , 15mmx9mmx 30mm , BICONVE...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0330150·Coronal Bender, Left

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0360150·Modular Tip, Bifid, Cross Offset, Right

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B0731010K0690150·Tray Insert, MIS Lumbar Instrument 4

    CARDIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD

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

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·April 17, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 21, 2011

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code LXH·June 19, 2008

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    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