528 results · 13ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.

FDA Recall
Terminated ·Smith & Nephew, Inc Endoscopy Division·Product code FWF·January 19, 2007

SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.

FDA Recall
Terminated ·Smith & Nephew, Inc Endoscopy Division·Product code FWF·January 19, 2007

FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code OFT·July 10, 2019

FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160

FDA Enforcement
Class II ·Terminated·B. Braun Medical, Inc.·September 11, 2019

Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S & 121820S

FDA Enforcement
Class II ·Terminated·NewDeal SA·July 25, 2018

Smart Perfusion Pack, REF: 084500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

FDA Recall
Terminated ·Sorin Group USA, Inc.·Product code DWF·December 30, 2009

SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·May 9, 2012

EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.

FDA Recall
Terminated ·Edwards Lifesciences Research Medical Inc·Product code DWF·November 19, 2004

Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·May 23, 2014

Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDnn242, EDNN243, and EDNN244.

FDA Recall
Terminated ·Ethicon, Inc. US·Product code DWF·April 27, 2006

Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm., Edwards Lifesciences

FDA Recall
Terminated ·Edwards Lifesciences Research Medical, Inc.·Product code DWF·April 18, 2006

Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813572. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·October 16, 2008

Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500500, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

FDA Recall
Terminated ·Sorin Group USA, Inc.·Product code DWF·October 7, 2010

Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500800, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

FDA Recall
Terminated ·Sorin Group USA, Inc.·Product code DWF·October 7, 2010

Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813572.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code DWF·May 22, 2007

Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813569.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code DWF·May 22, 2007

Terumo TenderFlow Pediatric Arterial Cannulae, 4.0mm (12 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813574.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code DWF·May 22, 2007

Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm self-inflating balloon, sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-M014S-L.

FDA Recall
Terminated ·Surge Medical Solutions, LLC·Product code DWF·April 17, 2007

Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass. Catalog Number: CB67532

FDA Recall
Terminated ·Medtronic Perfusion Systems·Product code DWF·May 9, 2008

Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with luer port 8.0mm (24Fr) OD with 3/8" connector, 14" (36cm) Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. long, with Xcoating" surface coating

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·February 23, 2012