39 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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MOSAIQ Oncology Information System
FDA Recall
Terminated
·Elekta, Inc.·Product code IYE·August 3, 2018
Post Medical Valves VO870A-Y and VO870-A-Y-T PSI 2015, PSI 2015, CGA 870, Inlet .750 STDS, Gas services (Oxygen), PSI 2015, Aluminum Cylinders, InterMed Gas Products LLC Industrial Division, 2056 Vista Parkway West Palm Beach, FL 33411.
FDA Recall
Terminated
·Intermed Gas Products Corporation·Product code ECX·March 27, 2009
On Site Gas Systems POGS 33C Portable Oxygen Generation System
FDA Recall
Terminated
·On Site Gas Systems Inc.·Product code CAW·December 19, 2013
On Site Gas Systems POGS 33C Portable Oxygen Generation System
FDA Enforcement
Class II
·Terminated·On Site Gas Systems Inc.·January 15, 2014
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
FDA Enforcement
Class II
·Terminated·Linde Gas North America Llc·June 26, 2013
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9016, Size (Fr) 16, # Eyelets 4, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9120, Size (Fr) 20, # Eyelets 4, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.
FDA Recall
Terminated
·International Biophysics Corp.·Product code DWS·August 7, 2015
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9040, Size (Fr) 40, # Eyelets 6, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
The Hemotherm 400CE 115v, containing power board p/n 39945
FDA Recall
Terminated
·Cincinnati Sub-Zero Products Inc·Product code DWS·November 7, 2016
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9028, Size (Fr) 28, # Eyelets 6, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9420, Size (Fr) 20, # Eyelets 2, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9036, Size (Fr) 36, # Eyelets 6, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures.
FDA Recall
Terminated
·Deroyal Industries, Inc. Lafollette·Product code DWS·February 6, 2020
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code DWS·January 13, 2020
Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4 mm, REF DP-44K e) 4.8 mm, REF DP-48K f) 5.2 mm, REF DP-52K g) 5.6 mm, REF DP-56K h) 6.0 mm, REF DP-60K i) 2.8 mm, REF MDP-28K j) 3.6 mm, REF MDP-36K k) 4.0 mm, REF MDP-40K l) 4.4 mm, REF MDP-44K m) 4.8 mm, REF MDP-48K n) 5.2 mm, REF MDP-52K o) 5.6 mm, REF MDP-56K p) 6.0 mm, REF MDP-60K
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code DWS·January 13, 2020
GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code GAS·May 3, 2013
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9012, Size (Fr) 12, # Eyelets 4, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·May 12, 2008
Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue Stabilizer is a disposable tissue stabilization system consisting of a rigid shaft, detachable tissue stabilizer headlink and a flexible articulating arm. The device is assembled within the thoracic cavity. Sterilized using ethylene oxide, non pyrogenic, disposable, single use only. The product is intended to stabilize and minimize the motion of selected areas of the beating heart during minimally invasive cardiac surgery procedures under direct visualization through a thoracotomy.
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DWS·September 13, 2010
Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA Product is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Not intended for use to deliver embolic agents or to perform angioplasty.
FDA Recall
Terminated
·Concentric Medical Inc·Product code GBS·February 27, 2009