BEUDAMED
    19 results · 20ms · Sources: EU EUDAMED, US FDA

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    Venus Bulk Flow ONE

    FDA 510(k)
    FDA Class 2 ·Dental

    Bernafon

    FDA UDI
    Sbo Hearing A/S·05714464011407·ALIGO 9 FW 1.0.0

    10PW - Amazon Delivery Van - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588206059·10PW - Amazon Delivery Van - Poly White

    Zavation

    FDA UDI
    Zavation LLC·00842166132818·Ti3Z CIF 14mmx16mmx5mm -6 deg

    Zavation

    FDA UDI
    Zavation LLC·00842166104907·CIF 14x16, 6 deg, -05

    BALFOUR CENTER BLADE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896097490·BALFOUR CENTER BLADE WIDE SIZE

    SANARUS VISICA TREATMENT SYSTEM

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

    PERMACOL SURGICAL IMPLANT

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

    PERMACOL 10X15 1.5MM

    FDA Adverse Event
    Death ·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

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

    MIS FEMORAL TRIAL EXTRACTOR

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·July 15, 2011

    PFC*SIGMA/OV/DOME PAT 3PEG,38

    FDA Adverse Event
    Injury ·9616671 DEPUY (IRELAND)·Product code JWH·July 11, 2013

    MECTACER BIOLOX OPTION HEADS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025

    BD MAX¿ ENTERIC VIRAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·February 23, 2024

    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 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: G73 Dry Bath Incubator Model/Catalog Number: K22065 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

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021