BEUDAMED
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    SL-PLUS LATERALIZED STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Reicodent

    FDA UDI
    devemed GmbH·04061644046706·Operating scissors 12 cm REGULAR CUT straight, ...

    BD MAX¿ ENTERIC PARASITE PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·February 23, 2026

    WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR

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

    CEDIA DAU 6-ACETYLMORPHINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011

    ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MPRI·Product code DTB·March 26, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 16, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·March 28, 2008

    ACTIS

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code MEH·April 9, 2026

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014