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

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    ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517275844·CoRoent Large MP Trial, 10x9x23mm 8°

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810118100·ACR MON #1 HC (QT 4 PER CASE)

    NuVasive

    FDA UDI
    Nuvasive, Inc.·00887517069702·Universal Light Cable Adapter, ACMI

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040012154·Zirlux 16+ 0M1 95X20

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967186672·Battalion, LLIF Trial, 10°, 18 mm Wide, 10 mm X...

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0111101·AWL, 10MM SPRING LOADED

    EPOC HOST

    FDA Adverse Event
    Malfunction ·EPOCAL INC.·Product code CGL·October 5, 2020

    URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·March 19, 2013

    TAYLOR SPATIAL HALF RING 155 MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS, INC.·Product code KTT·March 9, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 11, 2008

    PEDIMAG BLOOD PUMP

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DWG·June 13, 2024

    M2A ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018

    FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code KTT·October 11, 2013

    FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·February 26, 2014

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022