BEUDAMED
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    ETEST BENZYLPENICILLIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981135·anteriors; shade B1; mould CL2

    Symmetry

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482033302·Symmetry® Forceps, Pointed, Monopolar Handle w/...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756161589·SELF CLOSURE ELASTIC BANDAGE

    ZMR®

    FDA UDI
    Zimmer, Inc.·00889024160453·

    ZMR®

    FDA UDI
    Zimmer, Inc.·00889024160446·

    ZMR®

    FDA UDI
    Zimmer, Inc.·00889024160422·

    ZMR®

    FDA UDI
    Zimmer, Inc.·00889024160439·

    MED/SURG SHOE

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code IPG·May 8, 1997

    GEMINI CONDOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay

    FDA 510(k)
    FDA Unclassified ·Unknown

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·February 27, 2013

    REDO DOUBLE LUMEN TPN CATHETER SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DQO·July 23, 2014

    COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 8, 2011

    CONSTRAINED LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWZ·December 21, 2018

    ETEST FOSFOMYCIN FM 1024 WW B30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JWY·April 16, 2020

    ACETABULAR REVISION SYSTEM - CAGE, RIGHT LONG FLANGE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·December 26, 2018

    ACETABULAR REVISION SYSTEM - CAGE, RIGHT LONG FLANGE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·December 21, 2018

    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