BEUDAMED
    30 results · 23ms · Sources: EU EUDAMED, US FDA

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    EMBRYO VIEWER SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Comprehensive® Shoulder System

    FDA UDI
    Biomet Orthopedics, LLC·00880304460805·

    8960 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00817136020747·8960 PED SM MASK W/1420B 2W

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104080·Rod Curved 5.5 x 75mm

    Ø13mm Sacroiliac Falco Fusion Screw - L75mm

    FDA UDI
    McNicoll Chirurgical Inc.·07540161800185·Ø13mm Sacroiliac Falco Fusion Screw - L75mm

    SIros-X

    FDA UDI
    Genesys Orthopedics Systems LLC·M719GSIX1130750·SIros-X Awl Tipped Taps, 7.5mm

    SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BLUESHINE'S GOLD SERIES

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

    GEMSTAR DOCKING STATION

    FDA Adverse Event
    Other ·HOSPIRA, INC.·Product code FRN·August 1, 2011

    ALLIANCE GLENOID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·April 28, 2026

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 18, 2011

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 9, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014

    IMP TM 4.1MM MTX FULL, 11.5MM

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·May 13, 2022

    IMP TM 4.7MM MTX FULL, 10

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 30, 2024

    ECHELON ENDOPATH STAPLER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 4, 2025

    GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.

    FDA Enforcement
    Class I ·Terminated·Hospira Inc.·May 7, 2014

    GemStar Li-Ion Docking Station; a lithium ion battery powered docking station for use with GemStar Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; List Numbers 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13075-24-01, 13075-24-03, 13075-24-05 and 13075-24-07, Note: list numbers with xxxxx-04-xx are for U.S., Canada, Japan, Netherlands and Singapore, while those with xxxxx-24-xx are for international distribution only. The docking station for the GemStar pump is used to provide an alternate power source, acting either as a direct current battery backup, or as an alternating current power source when the docking station is plugged into AC power. The docking station also serves as a stand in which to place the GemStar during pump operation.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·August 1, 2011

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016