BEUDAMED
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    Vial2Bag Advanced® 20mm Admixture Device

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Pliers, TC, Wire-cutting, Power 23cm

    FDA UDI
    Geister Medizintechnik GmbH·04057034067802·Pliers, TC, Wire-cutting, Power 23cm ...

    BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PROCESS INDICATOR TAPE FOR STEAM STERILIZATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VASOVIEW HEMOPRO 2

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 17, 2011

    CORAIL AMT COLLAR SIZE 14

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS 3003895575·Product code KWA·November 10, 2014

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FKX·July 17, 2013

    Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the tracheobronchial respiratory pathways, in conjunction with endoscopic accessories. The bronchoscopes can also be used endoscopically to visualize the tracheobionchial respiratory tract via the natural passage (oral). Tracheoscope tubes are used as follows: 1. The tube is used as a passage to the area to be examined or treated and allows the insertion of auxiliary instruments such as forceps, resector, remover , suction device and stents; 2. The internal diameter allows the conveying of gases for artificial respiration of the patient and via the ventilation connector in conjunction with the telescope element, the tube can be connected to all known respiration and anasthetic systems; 3. Sampling channel for respiratory gas analysis when gas for analysis is gained from the patient s central respiratory tract by means of the bypass method via the tracheoscope tube. M = identification on Luer connector; 4.Tracheoscopes are used in the trachea up to the tracheal bifurcation.

    FDA Enforcement
    Class II ·Ongoing·Richard Wolf GmbH·February 13, 2019

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014

    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