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

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    LUXAFORM

    FDA 510(k)
    FDA Class 2 ·Dental

    Nobel

    FDA UDI
    Preat Corporation·00842092101841·Nobel Active/Conical RP Guide Pin 20mm

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092126066·NobelActive™/Conical-compatible RP Guide Pin 20mm

    TITANIUM COLIBRI FORCEPS WITH TYING WITH 0.3MM

    FDA UDI
    DAUD JEE MFG. CO·G006DT5050009510·This instrument is used to grasp, retract, or s...

    PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ACTICOAT FOAM DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    PAKAUTO ASSAY

    FDA Adverse Event
    Malfunction ·IMMUCOR GTI DIAGNOSTICS, INC.·Product code MZI·August 15, 2014

    OT VERIO PRO METER

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

    SJM EPIC VALVE

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL BRASIL LTDA.·Product code LWR·February 18, 2011

    EASY LOAD INSERTER

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code KYB·February 20, 2008

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    FDA Adverse Event
    Malfunction ·LUMIRADX UK LTD.·Product code QKP·April 14, 2023

    2CM PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 4, 2019

    2CM PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·October 7, 2019

    2CM PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·August 19, 2019

    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