BEUDAMED
    16 results · 24ms · Sources: EU EUDAMED, US FDA

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    PICO Single Use Negative Pressure Wound Therapy System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486000776·MCK Onlay Tibia Baseplate

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973107156·TRIAL 90-SRK-180614 POLY PS 6X14MM

    HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DR VISION NEO, DR VISION DOU

    FDA 510(k)
    FDA Class 2 ·Radiology

    CELL-DYN 3700 SL ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·February 22, 2019

    QUICKSITE LV

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

    INFUSOR

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

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code ITI·October 17, 2014

    WINGSET SEZSET 27X.38 12 W/O LUER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·October 11, 2021

    MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 9 MM

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·January 27, 2021

    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

    ROSA Brain 3.0 Application-Brain

    FDA Enforcement
    Class II ·Terminated·MEDTECH SAS·February 19, 2020

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022