BEUDAMED
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    VENTRIPOINT MEDICAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Surgical Direct

    FDA UDI
    Surgical Direct, Inc.·B382SD221081401530·10 3/4" Malis Bayonet Bipolar Forceps with Irri...

    Surgical Direct

    FDA UDI
    Surgical Direct, Inc.·B382SD220881401530·8 3/4" Malis Bayonet Bipolar Forceps with Irrig...

    SFC VERTEBRAL BODY REPLACEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    I-TEC PORTABLE DENTAL OPERATORY

    FDA 510(k)
    FDA Class 1 ·Dental

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 4, 2020

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 6, 2022

    ROD, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019

    5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 3, 2014

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 29, 2013

    SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHR·June 25, 2011

    POLARIS SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020

    PEDICLE SCREW UNSPECIFIED

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    PEDICLE SCREW UNSPECIFIED

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    PEDICLE SCREW UNKNOWN TYPE/SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·April 20, 2021

    CANNULATED TRANSLATION SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·December 3, 2020

    POLARIS TRANSLATION SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019