BEUDAMED
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    MANAN PROSTATE SEEDING NEEDLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Brigade

    FDA UDI
    Nuvasive, Inc.·00887517455963·Brigade HL Trial, 4x38x28mm 20°

    NA

    FDA UDI
    Zimmer, Inc.·00889024155985·

    NA

    FDA UDI
    Zimmer, Inc.·00889024155992·

    STERRAD 100NX STERILIZER EXPRESS CYCLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BIOSLEEP

    FDA 510(k)
    FDA Class 2 ·Neurology

    CS300

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP·Product code DSP·May 9, 2014

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013

    SOFTCLIX® LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·November 18, 2010

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

    Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 7, 2014

    Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

    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