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

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    Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486000752·MCK Onlay Tibia Baseplate

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973107149·TRIAL 90-SRK-180612 POLY PS 6X12MM

    POLYPROPYLENE

    FDA Adverse Event
    Malfunction ·CP MEDICAL·Product code GAW·September 6, 2019

    FM20

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LEICA FL800

    FDA 510(k)
    FDA Class 2 ·Radiology

    COVIDIEN

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024

    COVIDIEN

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024

    KANGAROO

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·January 28, 2026

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·April 26, 2022

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·October 17, 2014

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 27, 2011

    TENDRIL ST

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·June 20, 2013

    BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code JKA·February 14, 2019

    MCK TIBIAL ONLAY INSERT-SZ 2-8MM

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·June 17, 2016

    RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·May 16, 2018

    Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, REF 90-SRK-180410 e) Poly Component Trial - PS 4x12, REF 90-SRK-180412 f) Poly Component Trial - PS 4x14, REF 90-SRK-180414 g) Poly Component Trial - PS 5x10, REF 90-SRK-180510 h) Poly Component Trial - PS 5x12, REF 90-SRK-180512 i) Poly Component Trial - PS 5x14, REF 90-SRK-180514 j) Poly Component Trial - PS 6x10, REF 90-SRK-180610 k) Poly Component Trial - PS 6x12, REF 90-SRK-180612 l) Poly Component Trial - PS 6x14, REF 90-SRK-180614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·March 29, 2017

    Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, REF 90-SRK-180410 e) Poly Component Trial - PS 4x12, REF 90-SRK-180412 f) Poly Component Trial - PS 4x14, REF 90-SRK-180414 g) Poly Component Trial - PS 5x10, REF 90-SRK-180510 h) Poly Component Trial - PS 5x12, REF 90-SRK-180512 i) Poly Component Trial - PS 5x14, REF 90-SRK-180514 j) Poly Component Trial - PS 6x10, REF 90-SRK-180610 k) Poly Component Trial - PS 6x12, REF 90-SRK-180612 l) Poly Component Trial - PS 6x14, REF 90-SRK-180614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code JWH·February 20, 2017

    Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·March 9, 2016

    RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·December 1, 2017