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

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    Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon

    FDA 510(k)
    FDA Class 2 ·Radiology

    Dandy Clear Aligners

    FDA UDI
    Orthly, Inc.·00860006891206·

    BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code KZI·August 17, 2021

    MODULAR PROXIMALLY FLUTED HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SWIFT FX NANO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 17, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 24, 2011

    PI CVC KIT: 3-L 7 FR X 20 CM AGB

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code FOZ·August 7, 2014

    PLATE COLUMBIA AG 5PRCT SB 90MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code KZI·August 28, 2021

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQO·January 18, 2019

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·November 26, 2019

    THERMAGE CPT SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code GEI·November 12, 2020

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·November 26, 2025

    PLATE COLUMBIA AG 5PRCT SB 90MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code KZI·August 9, 2021

    THERMAGE CPT SYSTEM TIP

    FDA Adverse Event
    Injury ·SOLTA MEDICAL INC·Product code GEI·November 30, 2022

    Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a sterile, disposable kit, intended for one-time use for periods up to 6 hours, after which it must be discarded in a manner which is within applicable laws and practices. Terumo Cardiovascular System Cardiovascular Procedure Kits. Each kit is assigned a unique product code/catalog number that is specific to the consignee who has established specifications for the kit. US Product Codes: 72021 72358 71180-01 76021 76022 76023 76024 76025 71801-01 71801-01 71801-01 71801-01 71801-01 74163-03 71296-01 74460-01 74460-01 74460-01 73208-03 74382-01 74382-01 74382-01 74916 74916 74916 70089-07 74063-01 74063-01 74460-01 74460-01 74460-01 74460-01 75252-01 74951 75881 74271-01 71085-02 72742 75314 75368 75368 76095 76095 73339-01 73789 74417 72204 72965-03 73644 73645-01 73700 73861 73871 73901-03 75612 75617 75986 76095 73645-01 73645-01 70099-04 75544 75272 75674 75674 73180 73180 73180 75437 75674 75274 73811 73811 74915 71175-03 73738 76117 75129 75642 75642 72596 72596 72596 75179 74980-01 8340TXC-07 8340TXC-07 8340TXC-07 71875-01 74235-01 74476 75059 75547 75547 74235-01 8351TXC-01 73124 73281-01 73282-01 73874 74477 8340TXC-07 76069 76070 76071 76072 74737 73933 73933 73933 73933 73933 73933 71608-04 75413 74959 75472 75472 75449 75923 75923 73729-01 73730-01 74046-

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corp·September 7, 2016

    Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a sterile, disposable kit, intended for one-time use for periods up to 6 hours, after which it must be discarded in a manner which is within applicable laws and practices. Terumo Cardiovascular System Cardiovascular Procedure Kits. Each kit is assigned a unique product code/catalog number that is specific to the consignee who has established specifications for the kit. US Product Codes: 72021 72358 71180-01 76021 76022 76023 76024 76025 71801-01 71801-01 71801-01 71801-01 71801-01 74163-03 71296-01 74460-01 74460-01 74460-01 73208-03 74382-01 74382-01 74382-01 74916 74916 74916 70089-07 74063-01 74063-01 74460-01 74460-01 74460-01 74460-01 75252-01 74951 75881 74271-01 71085-02 72742 75314 75368 75368 76095 76095 73339-01 73789 74417 72204 72965-03 73644 73645-01 73700 73861 73871 73901-03 75612 75617 75986 76095 73645-01 73645-01 70099-04 75544 75272 75674 75674 73180 73180 73180 75437 75674 75274 73811 73811 74915 71175-03 73738 76117 75129 75642 75642 72596 72596 72596 75179 74980-01 8340TXC-07 8340TXC-07 8340TXC-07 71875-01 74235-01 74476 75059 75547 75547 74235-01 8351TXC-01 73124 73281-01 73282-01 73874 74477 8340TXC-07 76069 76070 76071 76072 74737 73933 73933 73933 73933 73933 73933 71608-04 75413 74959 75472 75472 75449 75923 75923 73729-01 73730-01 74046-

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code OEZ·July 25, 2016

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017