BEUDAMED
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    CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ACUFEX

    FDA UDI
    Smith & Nephew, Inc.·03596010090843·5 MM CANNULATED DRILL

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033507605·

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033507612·

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134080·Trial, TLIF, 27L OB STR 7Deg, 8mm

    UNBRANDED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033507629·

    FRESENIUS OPTIFLUX 200A

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

    WRISTWATCH BLOOD PRESSURE MONITOR A46

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 20, 2013

    OT ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 10, 2011

    TARGET TIP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 10, 2008

    IMPL TWIST MTX 3.75 MM 10 MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 17, 2024

    PHENOM CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code QJP·March 25, 2026

    PHENOM CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code QJP·January 9, 2026

    MALECOT NEPHROSTOMY CATHETERS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code GBO·May 22, 2025

    MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·October 23, 2013

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014