26 results · 23ms · Sources: EU EUDAMED, US FDA

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OsteoPack 3 FZ 22cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

FDA Recall
Terminated ·Regeneration Technologies, Inc.·Product code MQV·October 14, 2005

Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

FDA Recall
Terminated ·LivaNova USA Inc·Product code LYJ·November 16, 2018

Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

FDA Recall
Terminated ·LivaNova USA Inc·Product code LYJ·November 16, 2018

The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber.

FDA Recall
Terminated ·Fresenius Kabi, LLC·Product code LKN·April 19, 2011

ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.

FDA Recall
Terminated ·Pfm Medical Inc·Product code LJS·October 20, 2014

Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage

FDA Recall
Terminated ·Pfm Medical Inc·Product code GCB·October 20, 2014

ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.

FDA Recall
Terminated ·Pfm Medical Inc·Product code DWM·October 20, 2014

ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.

FDA Recall
Terminated ·Pfm Medical Inc·Product code DWM·October 20, 2014

ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.

FDA Recall
Terminated ·Pfm Medical Inc·Product code FJS·October 20, 2014

Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.

FDA Recall
Terminated ·Pfm Medical Inc·Product code GCB·October 20, 2014

Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.

FDA Recall
Terminated ·Pfm Medical Inc·Product code GCB·October 20, 2014

Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media.

FDA Recall
Terminated ·Pfm Medical Inc·Product code LJS·October 20, 2014

6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusions rate varies by catheter French size and is printed on the catheter.

FDA Recall
Terminated ·Pfm Medical Inc·Product code LJS·October 20, 2014

WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product labeling reads in part: "Well at Walgreens***WARM Helps relieve symptoms of stuffy nasal passages, congestion or scratchy throats due to cold, flu or allergies

FDA Recall
Terminated ·Bigwall Enterprises·Product code KFZ·November 20, 2015

Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length 12 Feet (3.7m), Sterile, Single Use, Disposable, Weck Closure Systems, Distributed by : Weck Closure Systems, One Weck Dr. Research Triangle Park, NC 27709, USA

FDA Recall
Terminated ·Product code FFZ·January 25, 2001

AxSYM CMV IgG Reagent Pack; list 04B47; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

FDA Recall
Terminated ·Abbott Laboratories·Product code LFZ·April 23, 2007

Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.

FDA Recall
Terminated ·Zeus Scientific Inc·Product code LFZ·June 12, 2003

Diamedix Is-CMV IgG Test Kit

FDA Recall
Terminated ·Diamedix Corporation·Product code LFZ·March 26, 2015

VIDAS 3 software v. 1.1.4

FDA Recall
Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code LFZ·January 11, 2017

VIDAS CMV IgG Assay

FDA Recall
Terminated ·bioMerieux·Product code LFZ·June 9, 2004