BEUDAMED
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    REGENSIS PERICARDIAL PATCH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 14, 2015

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·May 7, 2010

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58210514050·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489105657·PowerChem Neoprene Exam Gloves, Extra Large

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0154051·TRIAL, DRILL GUIDE 14 X 11, 5 MM TA

    EXEL INJECTION PLUG WITH CAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ASPIRATION PUMP, MODEL IMD-020

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

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 10, 2013

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·April 4, 2011

    ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code DXT·May 16, 2008

    Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=141mm, C=111mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-111.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·December 20, 2004

    Philips Zenition 70, Model Number: 718133

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

    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

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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