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

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    Sientra OPUS Silicone Gel Breast Implant Sizer

    FDA 510(k)
    FDA Unclassified ·Unknown

    STEVENS TENOTOMY SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896055490·STEVENS TENOTOMY SCISSORS LONG CURVED BLUNT BLA...

    Zavation

    FDA UDI
    Zavation LLC·00842166131781·Ti3Z CIF 12mmx14mmx6mm -7 deg

    Arena-C

    FDA UDI
    SPINEFRONTIER, INC.·00190361023050·12x15 Arena-C PEEK HA Straight 6mm

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756004398·POST-OP SHOE

    Manta Ray TDF

    FDA UDI
    Seaspine Orthopedics Corporation·10889981287689·Manta Ray TDF Spacer, 16x14x6mm, 7 Deg, Strl Asm

    DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EBV-VCA IGG ELISA TEST, MODEL EBG-100

    FDA 510(k)
    FDA Class 1 ·Microbiology

    AISYS

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016

    AXS VECTA 074 CATH 132CM - CE

    FDA Adverse Event
    Injury ·STRYKER NEUROVASCULAR-CALIF·Product code QJP·July 24, 2024

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 20, 2008

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013

    BD NANO¿ 2ND GEN PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 24, 2023

    NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V

    FDA Recall
    Terminated ·Product code JOS·September 30, 2004

    Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code KRA·August 10, 2005

    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.

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

    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 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