8 results · 23ms · Sources: EU EUDAMED, US FDA

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STA Satellite Max®

FDA 510(k)
FDA Class 2 ·Hematology

Micro C Medical Imaging System, M01

FDA 510(k)
FDA Class 2 ·Radiology

Target Detachable Coils

FDA 510(k)
FDA Class 2 ·Neurology

CONTAK RENEWAL 4 RF

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·November 11, 2008

GOBED II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·August 10, 2011

D-TRON PLUS

FDA Adverse Event
Malfunction ·ROCHE HEALTH SOLUTIONS INC·Product code LZG·July 30, 2013

DEKA SMARTPERIO

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code NVK·December 11, 2024

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