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

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    APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    9300

    FDA UDI
    HANS RUDOLPH, INC.·00874750009992·9326C 2600 W/9300 VLV & 9301

    EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ICONNECTION 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 31, 2022

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 14, 2013

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 29, 2011

    MAMMOTOME CONTROL MODULE WITH SMARTVAC -20/240V

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code KNW·August 12, 2008

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 29, 2024

    Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code MBI·April 23, 2019

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTN·February 22, 2017

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·July 25, 2018

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025