106 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. Product Usage: Sinus washing device to keep sinus passages clear of congestion.
FDA Recall
Terminated
·Water Pik, Inc.·Product code KMA·April 3, 2012
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge BEQ-TOP 38300 ADULT CPS QID Material:701055862R01
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge-BEQ-TOP 25503 TMC with BB & QiD Pedi Material:709000473
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Maquet Getinge BEQ-TOP 38300 ADULT CPS QID Material:701055862R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
FDA Recall
Terminated
·Datascope Corporation·Product code DTN·October 19, 2017
Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 25503 TMC ¿ with BB & QiD Pedi Material:709000473
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
FDA Enforcement
Class II
·Terminated·Medrad Inc·December 26, 2012
BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022
FDA Enforcement
Class II
·Terminated·Covidien LLC·September 9, 2015
Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures.
FDA Recall
Terminated
·Ormco Corporation·Product code EKM·September 9, 2010
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
FDA Recall
Terminated
·QiG Group LLC·Product code LGW·January 26, 2016
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 Recall
Terminated
·Water Pik, Inc.·Product code JET·July 2, 2018
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
FDA Recall
Terminated
·QiG Group LLC·Product code LGW·January 26, 2016
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
FDA Recall
Terminated
·QiG Group LLC·Product code LGW·January 26, 2016
MediSense Precision QID Blood Glucose Test Strips. The product is sold in box of 50 and 100. The NDC number for the 50 count box is 57599-7400-4. The NDC number for the 100 count box is 57599-7401-5.
FDA Recall
Terminated
·AmeriSource Bergen·Product code CGA·January 30, 2004