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

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    BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Asnis

    FDA UDI
    Stryker GmbH·07613154631421·CANNULATED SCREW

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048438003510·Irrigation/Suction Handle

    SCFE Screw

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132114605·4.0mm X 38mm SHORT THREAD CANNULATED SCREW

    SOLID STATE X-RAY IMAGING DEVICES

    FDA 510(k)
    FDA Class 2 ·Radiology

    HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RD SET YI

    FDA Adverse Event
    Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021

    M-LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

    M-LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

    RADICAL-7

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·February 19, 2016

    UNKNOWN MESH PRODUCT (EWHU)

    FDA Adverse Event
    Injury ·ETHICON SARL A JOHNSON & JOHNSON COMPANY·Product code FTL·March 24, 2011

    RAD-57 CONFIGURABLE PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·June 24, 2019

    SERVO-I

    FDA Adverse Event
    Injury ·MAQUET CRITICAL CARE AB·Product code CBK·March 28, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·March 21, 2011

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·April 15, 2008

    RAINBOW RC-4

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 11, 2017

    RD SET

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

    POLYMOBIL PLUS

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE GMBH·Product code IZL·July 27, 2023

    RD SET

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

    Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.

    FDA Enforcement
    Class II ·Terminated·Ondamed Inc·May 16, 2018