BEUDAMED
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    GEMINI CONDOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Philips GEMINI TF Big Bore (BB) Diagnostic Imaging Systems, Model Number: 882476, 510(k) #K081135, Serial Numbers: 9201, 9202, 9203, 9204, 9205, and 9206. The recalled GEMINI TF Big Bore system units equipped with software version: 3.6.1 are subject to recall/software correction. The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·May 31, 2011

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517320490·CoRoent® LO Ti, 11x10x35mm 5°

    PRO-DEX, INC.

    FDA registration
    PRO-DEX, INC.·9 products·🇺🇸 United States

    6F & 7F INTRODUCING CATHETERS (MODIFICATION)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GSI AUDERA

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·April 26, 2013

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·September 5, 2014

    MICROSMART

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code LOS·April 14, 2011

    OSOM HCG URINE TEST (RAPID CLINICAL LABORATORY ASSAY) N/A

    FDA Adverse Event
    GENZYME DIAGNOSTICS (SAN DIEGO)·Product code JHI·August 5, 2009

    DAVINCI SI

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 4, 2020

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·December 31, 2024

    OSOM HCG URINE TEST (RAPID CLINICAL LABORATORY ASSAY) N/A

    FDA Adverse Event
    GENZYME DIAGNOSTICS (SAN DIEGO)·Product code JHI·August 13, 2009

    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