7 results
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7ms
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Sources: EU EUDAMED, US FDA
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
FDA Enforcement
Class II
·Terminated·Medtronic·December 28, 2016
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
FDA Enforcement
Class II
·Terminated·Avanos Medical, Inc.·June 14, 2023
AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
FDA Enforcement
Class II
·Terminated·Avanos Medical, Inc.·June 14, 2023
The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·April 12, 2017
Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 3, 2014
Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.
FDA Enforcement
Class II
·Terminated·Water Pik, Inc.·August 15, 2018
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only."
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 2, 2016