185 results
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16ms
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Sources: EU EUDAMED, US FDA
3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.
FDA Recall
Terminated
·Mindray DS USA, Inc. dba Mindray North America·Product code MSX·May 27, 2021
Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the following model numbers (all using the same box label): Model 7000 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; Model 7030 - Consisting of the Aeroneb Go, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7070 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7000-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, European mask elbow, mouthpiece, carry bag, and user manual; Model 7030-1 - Consisting of the Aeroneb Go, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual; Model 7070-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual. 7000LINCARE - Consisting of the Aeroneb Go, battery controller with a Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; 7070LINCARE - Consisting of the Aeroneb Go, battery controller with the Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual.
FDA Recall
Terminated
·Medical Industries America Inc·Product code CAF·September 7, 2004
The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.
FDA Recall
Terminated
·Miami Fat Supply, Inc·Product code MUU·April 21, 2016
Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied.
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·July 18, 2019
AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
FDA Recall
Terminated
·Product code MIH·December 27, 2016
AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
FDA Recall
Terminated
·Product code MIH·December 27, 2016
AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
FDA Recall
Terminated
·Product code MIH·December 27, 2016
AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
FDA Recall
Terminated
·Product code MIH·December 27, 2016
GORE EXCLUDER AAA Endoprosthesis
FDA Recall
Terminated
·W. L. Gore & Associates Inc.·Product code MIH·January 6, 2020
Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.
FDA Recall
Terminated
·Paa Laboratories Inc
145 Bethridge Road
Etobicoke Canada Ontario·Product code KIS·April 12, 2013
DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). The DDC-6-AA data card is an accessory to the AED and does not have its own intended use.
FDA Recall
Terminated
·Defibtech, LLC·Product code MKJ·August 27, 2010
AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V f00553 I1616/C55F SA F00556 I2013/C70F SA F00555 I2020/C55F SA F00558 IS2025/C55 SA F00559 IS2025/C65 SA F0072605 A2525/C75O20 V F0072606 A2525/C95O20 V f00552 I1616/C88 SA F00557 I2013/C88F SA The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA
FDA Recall
Terminated
·Product code MIH·January 4, 2017
AFX Endovascular AAA System, Endoleak Type IIIA
FDA Recall
Terminated
·Product code MIH·December 27, 2016
Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-30-39, REF G32183, 20 Fr. ID/ 7.7 OD, Sterile.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·April 15, 2011
Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-22-29, REF G32179, 18 Fr. ID/ 6.90 OD, Sterile.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·April 15, 2011
Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-32-39, REF G32184, 20 Fr. ID/ 7.7 mm OD, Sterile.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·April 15, 2011
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48469, 16Fr ID/ 6.0 mm OD, Sterile.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·April 15, 2011
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-56-ZT, REF G48461, 16Fr ID/ 6.0 mm OD, Sterile.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·April 15, 2011
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-90-ZT, REF G48471, 16Fr ID/ 6.0 mm OD, Sterile.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·April 15, 2011
Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-90-ZT, REF G48463, 16Fr ID/ 6.0 mm OD, Sterile.
FDA Recall
Terminated
·Cook, Inc.·Product code MIH·April 15, 2011