BEUDAMED
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    GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014609287·SKYTRON 5.25" DELUXE GEL

    CD3-VioGreen

    FDA UDI
    Miltenyi Biotec B.V. & Co. KG·04049934133954·BW264/56 recognizes the human CD3 antigen which...

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 15, 2023

    CLASSIC CEM

    FDA 510(k)
    FDA Class 2 ·Dental

    BEHRING COAGULATION TIMER ANALYZER (BCT)

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 5, 2024

    STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.

    FDA Enforcement
    Class III ·Terminated·Advanced Sterilization Products·December 11, 2013

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·April 10, 2013

    MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 45 MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code NKB·April 14, 2011

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 21, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025