BEUDAMED
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    SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TELEPAX

    FDA 510(k)
    FDA Class 2 ·Radiology

    NYLON, NONABSORBABLE SURGICAL SUTURES USP

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

    REVEAL DX

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·April 10, 2013

    LIFEPAK 20 DEFIBIRLLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·May 22, 2008

    UNKNOWN ZIMMER KNEE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·April 6, 2011

    OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·March 26, 2025

    GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6 Slice scanning device configurations. Model Numbers: 4535-679-71891 and 4535-6797591, 510(k) #K051170.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·January 26, 2009

    Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·May 29, 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