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

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    CorPath GRX System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486000660·MCK Femoral Component

    INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    RESICEM

    FDA 510(k)
    FDA Class 2 ·Dental

    PRECISION SPECTRA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 18, 2019

    ORTHOPEDIC STEREOTAXIC INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code OLO·April 5, 2019

    MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 7 - 8 MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code NPJ·March 23, 2021

    MCK TIBIAL BASEPLATE-RM/LL-SZ 7

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·June 11, 2019

    COBAS 8000 E602 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·January 23, 2015

    AUTOLUBE-III WITH IRRIGATION AND MA7

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GEY·October 17, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 20, 2013

    1823260-2015-04467

    FDA Adverse Event
    Malfunction ·November 9, 2015

    MAKO UKR X3 ONLAY INSERT SIZE 7 - 8 MM

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·May 1, 2025

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·June 6, 2018

    Stryker Ureteral Universal Kit, Model number 220-180-517, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The device is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures of the lower abdomen or pelvic areas to help the surgeon identify the ureter.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code FCS·May 9, 2008

    ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·August 16, 2023

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024