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

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    Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set

    FDA 510(k)
    FDA Class 2 ·Neurology

    Dornier MedTech

    FDA UDI
    DORNIER MEDTECH AMERICA, INC.·00810116023271·270 Micron SU Thulio Slim Performance 3m Fiber

    ACTEON

    FDA UDI
    ACTEON MANUFACTURING·03760243000010·Ribbon for stabilization of mobile teeth

    CODMAN

    FDA UDI
    Cerenovus, Inc.·10886704001539·CODMAN SLIM-LINE Aneurysm Clip Bayonet Blade Le...

    RINGLOC CONSTRAINED LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MYRAY HYPERION

    FDA 510(k)
    FDA Class 2 ·Dental

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014

    UNK NEXGEN LPS-FLEX FEMORAL

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·June 28, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·April 18, 2022

    ONYX

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code MFE·January 23, 2017

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code MIH·April 20, 2018

    MISC ORTHO SURGICAL INSTR

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code LXH·June 26, 2018

    Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code LRO·August 15, 2007

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020

    Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021