BEUDAMED
    22 results · 22ms · Sources: EU EUDAMED, US FDA

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    TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Bur PM2-95 80K Diam Ø2.3 St

    FDA UDI
    Bien-Air Surgery SA·17630055502930·

    Bur PM2-95 80K diamond Ø2.3mm sterile

    FDA UDI
    Bien-Air Surgery SA·J00711003220011·

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517635440·CoRoent Ant TLIF PEEK, 10x10x32mm 12°

    InSync Ceramic System

    FDA UDI
    JENSEN INDUSTRIES INC.·00817340023367·

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037312186·PROTECTOR Ø41mm

    PALODENT PLUS PIN TWEEZERS

    FDA Adverse Event
    Malfunction ·DENTSPLY LLC·Product code DZN·April 11, 2024

    MODIFICATION TO CAPSURE PS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD PIVO BLOODCOLLECTON

    FDA Adverse Event
    Injury ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code JKA·January 11, 2024

    Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TGS UKA SYSTEM

    FDA Adverse Event
    Injury ·CAYENNE MEDICAL, INC·Product code HSX·February 12, 2014

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 8, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 18, 2014

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 16, 2011

    SMR REVERSE HUMERAL BODY SHORT

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code PHX·July 25, 2023

    ADULT DUAL-HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·August 23, 2011

    Tracheostomy Tubes, Jackson Improved Short Stainless Steel with Adapter, item number 8100402 size 3,item number 8100040 size 4, item number 8100041 size 5, item number 8100229 size 6, item number 8100322 size 7, item number 8100374 size 8, item number 8100282 size 9, and item number 8100709 size10.

    FDA Recall
    Terminated ·Premier Dental Products Co·Product code JOH·August 5, 2004

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025