10 results
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43ms
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Sources: EU EUDAMED, US FDA
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PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
FDA Enforcement
Class II
·Ongoing·Richard Wolf GmbH·May 21, 2025
RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
FDA Enforcement
Class II
·Terminated·Richard Wolf GmbH·May 23, 2018
Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages.
FDA Enforcement
Class II
·Ongoing·Richard Wolf GmbH·August 29, 2018
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
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
FDA Enforcement
Class II
·Ongoing·Richard Wolf GmbH·May 3, 2023
CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
FDA Enforcement
Class II
·Terminated·Richard Wolf GmbH·August 18, 2021
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685
FDA Enforcement
Class II
·Ongoing·Richard Wolf GmbH·May 3, 2023
FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685
FDA Enforcement
Class II
·Ongoing·Richard Wolf GmbH·May 3, 2023
FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
FDA Enforcement
Class II
·Ongoing·Richard Wolf GmbH·May 3, 2023
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged.
FDA Enforcement
Class II
·Terminated·Richard Wolf GmbH·August 5, 2020