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

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    CINA-VCF

    FDA 510(k)
    FDA Class 2 ·Radiology

    SpheRx

    FDA UDI
    Nuvasive, Inc.·00887517813701·SpheRx II Gearshift Probe, Curved

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037318218·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC MOBILITY ...

    devemed

    FDA UDI
    devemed GmbH·04061644013364·Caliper "Castroviejo" | 9 cm straight / 0-40 mm

    Reicodent

    FDA UDI
    devemed GmbH·04061644049875·Caliper "Castroviejo" | 9 cm straight / 0-40 mm

    Tiger Shark System

    FDA UDI
    Choice Spine, LP·00840996165990·TIGER SHARK,STERILE,STR,9X24X6,12 DEG

    SKY BONE EXPANDER SYSTEM (SKY SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    R501 aortic root cannula without vent line, R502 aortic root cannula with vent line

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NAIL HOLDING SCRE WGAMMA3 8X35MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 21, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 10, 2014

    SERVING TRAY, GRAY

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 22, 2013

    CAMLOG SCREW LINE IMPLANT 3.8X13

    FDA Adverse Event
    Injury ·ALTATEC GMBH·Product code DZE·January 30, 2008

    UNSPECIFIED BD VACUTAINER® TUBE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JKA·September 11, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code QBJ·June 28, 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 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 Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.

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

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.

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

    BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

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