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

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    Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)

    FDA 510(k)
    FDA Class 2 ·Dental

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025026·R65 Trolley

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037318300·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC STABILITY...

    Burr

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113103·PTERYGIUM DRILL MEDIUM DIAMOND BURR

    Tiger Shark System

    FDA UDI
    Choice Spine, LP·00840996166027·TIGER SHARK,STERILE,STR,9X24X9,12 DEG

    SOMATOM SCOPE/SOMATOM SCOPE POWER

    FDA 510(k)
    FDA Class 2 ·Radiology

    HYDROGEL CANALICULAR PLUG

    FDA 510(k)
    FDA Unclassified ·Unknown

    8.5MM MEDULLARY REAMER HEAD

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HTO·November 10, 2014

    PYXIS ANESTHESIA SYSTEM (PAS)

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code BRY·August 8, 2011

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 22, 2013

    REVOLUTION 5

    FDA Adverse Event
    Injury ·MIRANDOLA·Product code KFM·August 8, 2025

    Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024

    BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

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

    BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.

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

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.

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

    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 Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

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

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

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

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

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