BEUDAMED
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    DEPUY CI HIP INSTRUMENTATION

    FDA 510(k)
    FDA Class 2 ·Neurology

    NA

    FDA UDI
    STERILMED, INC.·10888551020411·SAW BLADE OSCILLATING LARGE BONE

    CONMED

    FDA UDI
    Conmed Corporation·10845854003985·OSCILLATOR BLADE, 5 X 30 X 0.6 MM (.024")

    6F & 7F INTRODUCING CATHETERS (MODIFICATION)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GSI AUDERA

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

    3M BAIR HUGGER WARMING UNIT 775

    FDA Adverse Event
    Malfunction ·3M HEALTH CARE·Product code DWJ·April 8, 2013

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 27, 2011

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 20, 2017

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 15, 2017

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 20, 2017

    TOSOH HLC-723G8 ANALYZER

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·December 11, 2017

    BIOLOX HEAD HIP IMPLANT

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·April 25, 2019

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code LCP·January 5, 2016

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Injury ·TOSOH CORPORATION·Product code LCP·January 3, 2017

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·April 16, 2018

    UNKNOWN BIOLOX HEAD

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·February 13, 2018

    CERASUL, HEAD, M/0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·November 4, 2019

    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

    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