BEUDAMED
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    CANDELA SMOOTHBEAM LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Hegar Dilator

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803030834·Hegar Dilator 7-8mm

    Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

    FDA UDI
    TENON MEDICAL, INC.·B74240308340·7.5mm Funnel

    CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO

    FDA 510(k)
    FDA Class 1 ·Dental

    SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RESOLUTION CLIP CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·April 2, 2013

    TERUMO STERNAL SAW II

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GFA·March 4, 2011

    RAPIDLAB 1265 BLOOD GAS SYSTEM

    FDA Adverse Event
    Other ·SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.·Product code CHL·April 17, 2008

    AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·August 10, 2016

    8) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) Signa 3.0T with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa@ Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    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