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

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    OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1

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

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964008724·Endo Carry-On Procedure Kit

    PowerPICC Provena

    FDA UDI
    Bard Access Systems, Inc.·00801741189128·Catheter Placement Kit

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925028913·Single Incision Inner Tube Assembly

    TUFF TT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·May 6, 2025

    ACCUTRANS Disposable Pressure Monitoring Kit

    FDA UDI
    BIOPTIMAL INTERNATIONAL PTE. LTD.·08886483504257·

    TUFF TT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·May 6, 2025

    SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RGP MULTI-PURPOSE SOLUTION ID 100136

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CEMENTED GLENOID SMALL

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWT·September 21, 2020

    EASYPUMP

    FDA Adverse Event
    Other ·I-FLOW CORP.·Product code MEB·September 10, 2007

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013

    UNKNOWN ZIMMER MIS TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·February 18, 2011

    JUVEDERM ULTRA

    FDA Adverse Event
    Injury ·CORNEAL·Product code LMH·February 20, 2008

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024