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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas. Hem-o-lok Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures.
FDA Recall
Terminated
·Teleflex Medical·Product code FZP·February 2, 2016
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code FZP·April 16, 2021
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code FZP·April 16, 2021
AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code FZP·June 22, 2016
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·November 14, 2018