BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    3M Attest Steam Chemical Integrator Test Pack

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IRIS SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896055612·IRIS STILLE SCISSORS CURVED BLADES LARGE RING P...

    HL168F

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRI-FIX SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    OLYMPUS ELECTROSURGICAL UNIT UES-40

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code KNS·July 28, 2011

    TOTAL ASR ACET IMP SIZE 44

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 1, 2013

    BRYAN CERVICAL DISC SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code MJO·April 22, 2014

    BRYAN CERVICAL DISC SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code MJO·April 22, 2014

    BRYAN CERVICAL DISC SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code MJO·April 22, 2014

    UNK - ELASTIC NAILS: TITANIUM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code JDS·May 4, 2021

    UNK - ELASTIC NAILS: TITANIUM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code JDS·May 4, 2021

    UNK - ELASTIC NAILS: TITANIUM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code JDS·May 4, 2021

    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

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018