BEUDAMED
    19 results · 32ms · Sources: EU EUDAMED, US FDA

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    SKYHAWK LATERAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OMNI Knee

    FDA UDI
    Omni Life Science, Inc.·00841690101901·All Poly 3 Peg Patella 26 mm x 10 mm

    Cancellous Screw, Cannulated

    FDA UDI
    I.T.S. GmbH·09120034302312·Cancellous Screw, Cannulated, D=4.0mm, L=60mm, ...

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981179793·Z-Rod, Dia. 6.0mm, Co-Cr, 260mm

    NEWTOM 5G / NEWTOM 5G VERSION FP

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTEGRAL HEMODIALYSIS CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 17, 2023

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·July 19, 2021

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 3, 2023

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 10, 2021

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·October 11, 2022

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·October 2, 2020

    T:FLEX INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·July 13, 2017

    QUADRA-H CEMENTLESS, HA COATED STEM 3 LAT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·September 30, 2016

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 31, 2013

    PNEUMO SURE XL HIGH FLOW INSUFFLATOR

    FDA Adverse Event
    Injury ·STRYKER ENDOSCOPY SAN JOSE·Product code HIF·June 15, 2011

    RSVR MMT-326A 10PK PRDGM 1.8ML 13L

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code FMF·August 29, 2008

    PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 33CM, P/N 0250080694 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 16, 2018