BEUDAMED
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    SLEEVE AND BUTTON SOFT TISSUE DEVICES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125549·PowerChem Neoprene Exam Gloves, Large

    NPAC EAR THERMOMETER MODEL TD 402

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ATHOS

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

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 22, 2022

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·April 22, 2013

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 15, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN BENNETT CORP·Product code CBK·July 9, 2008

    PINN CAN BONE SCREW 6.5MMX15MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018

    SUMMIT POR TAPER SZ6 STD OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018

    PINN CAN BONE SCREW 6.5MMX25MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·October 7, 2020

    Apex Pilot Shaft 16mm

    FDA Recall
    Terminated ·Apex Surgical, LLC·Product code HTO·January 17, 2003

    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

    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018