BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    HPR45i

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

    Ambler Surgical

    FDA UDI
    AMBLER SURGICAL CORP.·00190660194703·Corneal trephine blade, short, 8.0mm length, 7....

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197530361·Tebbet Breast Retractor 220x25...

    Citregen Tendon Interference Screw and Citrelock

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD 60ML SYRINGE LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 5, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 3, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 23, 2011

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·July 8, 2013

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.·Product code JKA·May 8, 2024

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Identity Shoulder System Resection Planer 35mm Resection Planer

    FDA Enforcement
    Class II ·Ongoing·Zimmer, Inc.·February 15, 2023

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015

    Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020