BEUDAMED
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    ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139243769·UNITY KNEE™ PS-C INSERT - Size 3 x 16mm

    ATLANTIS® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000889142·SCREW 3120316 4.0 X 16 SELF TAP VAR

    ATLANTIS® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994239648·SCREW 3120316 4.0 X 16 SELF TAP VAR

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113188·PS Insert, Size 3 x 16mm

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319720233·Feilchenfeld Splinter Forceps 3" (7.5cm), straight

    CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ARCHITECT HBSAG

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·March 30, 2026

    ARCHITECT HIV AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code MZF·March 30, 2026

    1030489-2016-01695

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·June 7, 2016

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 21, 2012

    1.5X5MM RAPIDFIRE SCREWS,5PK

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·May 20, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·September 26, 2014

    TI LOW PROFILE TRANSCONNECTOR 31.5MM-34MM FOR 6.0MM RODS

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code NKB·June 2, 2011

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·April 29, 2013

    ALINITY C PROCESSING MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·April 3, 2025

    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.

    FDA Enforcement
    Class II ·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015